Johnson & Johnson Vision (J&J Vision) is pursuing litigation in several countries, including the United States, to resolve an intellectual property dispute against Alcon, according to a prepared statement.

The lawsuit, filed in the U.S. District Court in Delaware, alleges that Alcon’s LenSx Femtosecond Laser Systems infringe on J&J Vision’s JJV's copyrighted source code as well as certain patents relating to the CATALYS Precision Laser System.

Alcon has also asserted patent infringement claims against J&J in the United States and in Europe relating to J&J’s Catalys femtosecond laser system. Both parties have asserted that the other’s patents are invalid, and both parties deny infringing the other party’s patent rights.

In February, J&J Vision filed a motion for a preliminary injunction against Alcon in its U.S. case, asking the court to prevent Alcon from selling new and refurbished LenSx femtosecond laser systems while the suit is pending.

Last week, the court ruled that a preliminary injunction was not warranted because the injuries claimed by J&J, if proven at trial, would be adequately compensated by money damages and J&J waited more than six years to file suit.

Alcon released a statement today saying the company “is confident in its position and will continue to defend its rights and prosecute its claims of patent infringement against J&J Vision in the United States and Europe.”

Alcon also was buoyed by the District Court ruling denying J&J Vision’s request for a preliminary injunction.

“For the benefit of customers and patients around the world, and consistent with that ruling, Alcon will continue to sell, install and service LenSx Laser Systems,” the statement concluded. “As a matter of corporate policy, we have no further comment on pending or ongoing litigation.”

Articles

After a US District judge rules against request for preliminary injunction, Johnson & Johnson Vision moves forward with litigation in several countries, including the United States, to resolve intellectual property disputes against Alcon.

Johnson & Johnson Vision, Alcon engaged in intellectual property dispute

This image is a pre-treatment photo of the fundus. (Image courtesy of Friederike Kortuem, MD, MSc)

Reviewed by Friederike C. Kortuem, MD, MSc

Treatment with voretigene neparvovec-rzyl (Luxturna, Novartis) resulted in a short-term change in the foveal morphology in a 15-year-old girl with visual impairment that included nyctalopia and decreased visual acuity (VA) in early childhood, according to Friederike Kortuem, MD, MSc, from Eye Clinic Tübingen, University of Tübingen, Tübingen, Baden-Württemberg, Germany.

Speaking at the Association for Research in Vision and Ophthalmology’s virtual 2021 annual meeting, Kortuem point out that visual deterioration generally occurs early in Leber’s congenital amaurosis type 2 (LCA2) and early-onset severe retinal dystrophy (EOSRD), as soon as birth to 5 years of age.

Characteristically, rapid degeneration of the rods and cones, visual field reduction, sluggish or near-absent pupillary responses, photophobia, nystagmus, and nyctalopia can occur. By the 4th decade of life, patients usually are legally blind. 

Subretinal administration of voretigene naparvovec-rzyl in an adeno-associated viral vector was FDA-approved in the US in 2017 and in Germany in 2019 to treat retinal dystrophies caused by bi-allelic RPE65 mutations; RPE65 is involved in the vitamin A restoration cycle in the eye.

The current patient had an RPE65 homozygous mutation. The VA in the right eye at examination was 20/63, and the anterior segment was unremarkable. The retinal examination in that eye showed central macular atrophy, narrowed vessels, and diffuse peripheral atrophy.

Kortuem demonstrated the overall decreased retinal thickness in the right eye.

Clinical examinations included measurement of the best-corrected VA (BCVA), spectral-domain optical coherence tomography (OCT), and adaptive optics retinal imaging.

At baseline, the patient was injected with the gene therapy vector that was successfully positioned between the neural retina and the retinal pigment epithelium. She was evaluated at baseline and then 2 and 5 weeks and 3 months following treatment.

At baseline, compared with healthy individuals of the same age, this patient’s retina was thinner. Kortuem showed that the central fovea had alterations in its layers and the retinal structures were not well demarcated, in contrast to the parafoveal layer with a preserved outer retina and photoreceptors.

As soon as 2 weeks after treatment, the foveal layer started to change. The external limiting membrane was visualized in the fovea.

“The overall disrupted appearance improved,” she pointed out.

After 5 weeks, the layering of the central fovea improved more out to 3 months.

The adaptive optics images obtained at baseline showed a mosaic of disrupted photoreceptor cells, that according to Kortuem, is characteristic of inherited retinal diseases. Following treatment, the superior nasal area appeared partly clear and the cones were identifiable. In the first 5 weeks following treatment, the initially patchy areas seemed to be decreasing over time. These morphologic rescue parameters changed gradually over time and were correlated partly with the improvement in the foveal-mediated vision after the treatment.

Regarding the safety of the treatment, no signs of inflammation were observed.

The cone functionality improved a bit and the patient reported “brighter” vision, which she also reported 5 weeks after surgery. At 3 months after surgery, the objective changes persisted.

The VA remained stable from baseline to week 5 and then improved by 1 line to 20/50. The contrast sensitivity also remained stable over time.

Chromatic pupil campimetry showed a dramatic increase in the central 10 degrees of the pupil from week 2 to week 5 and this improvement persisted to month 3.

“Rapid changes in the photoreceptor morphology seen on OCT and adaptive optics imaging after successful gene therapy in patients with LCA and EORD can be quantifiable at the individual level,” Kortuem concluded.

This article is adapted from Kortuem’s presentation at the Association for Research in Vision and Ophthalmology virtual annual meeting. She has no financial interest in this subject matter.

In a presentation at ARVO, Friederike Kortuem, MD, MSc, explains that treatment with voretigene neparvovec-rzyl led to a short-term change in the foveal morphology in a patient with visual impairment that included nyctalopia and decreased visual acuity in early childhood. 

Treatment with voretigene neparvovec-rzyl results in foveal morphologic changes in LCA 

Dr Michael A. Singer of the Medical Center Ophthalmology Associates in San Antonio, Texas, speaks on the highlights of his presentation focusing on intraocular pressure (IOP) in the PALADIN 24-month data intravitreal steroid (ILUVIEN), presented during ARVO 2021. 

Videos

Dr Michael A. Singer speaks on the highlights of his presentation focusing on IOP in the PALADIN 24-month data intravitreal steroid (ILUVIEN).

Focusing on 24-month data of the PALADIN study

Dr Mohamed Abou Shousha and Dr Richard Parrish II both of the University of Miami Health System Bascom Palmer Eye Institute, discuss their ARVO 2021 presentation regarding a study analyzing visual field measurements using the 

 Visual Field Multi-platform application downloaded on two different commercially available augmented reality devices.

Note: Dr Shousha is also CEO and founder of Hero

Dr Mohamed Abou Shousha and Dr Richard Parrish II discuss their ARVO 2021 presentation regarding a study analyzing visual field measurements using the Heru Visual Field Multi-platform application downloaded on two different commercially available augmented reality devices.





Measuring visual fields with cloud-based AI platform

This treatment fills a gap for patients who are unresponsive and/or intolerant to the standard treatments for noninfectious keratitis, such as lubricants, corticosteroids, and immunosuppressants. 

Few treatments are available for this patient population with advanced disease, according to Joseph Grieco, PhD, director of Clinical Development at Mallinckrodt Pharmaceuticals in Bedminster, New Jersey.

Grieco explained that RCI works via its anti-inflammatory and immunomodulatory effects through interaction with melanocortin receptors.


Grieco and his colleagues conducted a multicenter, open-label, phase 4 study to evaluate the efficacy and safety of RCI in patients with refractory severe non-infectious keratitis. 

The primary efficacy endpoint was the proportion of patients with improvements in the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire score by 12 or more points. 

The Visual Analogue Scale (VAS) for burning/stinging and eye discomfort, and corneal fluorescein staining were exploratory endpoints for the study. 

The safety endpoints were the proportion of patients with treatment-emergent or serious adverse effects during the study.

The study included 36 patients (mean age, 63.3 years; 71.4% women; 80% Caucasian). All patients had bilateral keratitis (mean duration, 4.4 years). Patients administered 80 units of RCI twice a week for 12 weeks followed by tapering for 4 weeks.

Grieco explained that the IDEEL symptom bother score at week 12 after the start of treatment showed that 50% of patients had greater than a 12-point improvement, and 52.9% achieved that level of improvement as early as week 2 after treatment initiation.

“The mean changes from baseline in the symptom bother score exceeded the minimal clinically important difference threshold at every evaluation point,” he said.

At the 12-week evaluation, the VAS score indicated that all symptoms improved from baseline, with the most pronounced improvements seen in ocular dryness and discomfort.

Improvements in corneal and conjunctival staining also were seen as soon as 4 weeks after treatment started and were sustained through week 12. 

The mean change went from 5.3 at baseline to -1.0 at week 4 and was sustained to week 12 at -1.1.

A third of patients had an adverse effect during the study, most of which occurred once. The intraocular pressure did not increase.

“The results of this open-label study showed that 80 units of RCI twice weekly for 12 weeks was associated with rapid and sustained improvements in the symptoms of persistent severe noninfectious keratitis that had previously not responded to standard-of-care therapies,” Grieco concluded. 


This article is adapted from Grieco’s presentation at the Association for Research in Vision and Ophthalmology’s 2021 virtual annual conference. He is an employee of Mallinckrodt Pharmaceuticals. RCI is approved by the FDA for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, including keratitis.


1. Huang YJ, Galen K, Zweifel B, et al. Distinct binding and signaling activity of Acthar Gel compared to other melanocortin receptor agonists. J

Joseph Grieco, PhD, notes that treatment fills a gap for patients who are unresponsive to the standard treatments for noninfectious keratitis. 

Injections offer relief for refractory severe noninfectious keratitis

An experimental study of hemorrhagic shock conducted in rabbits found that during progression of and recovery from shock, the blood flow in the eye shows decreases and increases similar to those seen in the kidney and intestines. 

Noninvasive measurement of the blood flow in the eye may be a new indicator of shock-related organ damage, reported Kento Watanabe, MD, from the Department of Ophthalmology, Toho University School of Medicine, Tokyo, and Tomoaki Shiba, MD, from the Department of Ophthalmology, International University of Health and Welfare Narita Hospital, Funabashi, Chiba, Japan.

While shock is defined as the progression of organ disorders, it is difficult to evaluate using only parameters such as blood pressure. 

Fundus examination is the only examination that facilitates direct observation of an organ’s blood supply, which reflects the true nature of shock. 

Evaluation of the retinal vessels is a valuable resource because they have the same function and structure as the coronary and renal arteries, Watanabe explained.

Watanabe and his colleagues used laser speckle flowgraphy (LSFG) to study the relationship between whole body and ocular blood flow in small- and medium-sized animals and they found previously that the ocular blood flow index obtained using LSFG accurately reflects the blood pressure and cardiac output during shock, and that the ocular blood flow is larger than the rate of decrease in cardiac output (unpublished data).

In the study, shock was induced in 10 New Zealand white rabbits by removing blood at the rate of 1 mL/minute for 30 minutes; the animals were observed for 20 minutes and the blood returned. 

During the period of shock, the mean arterial blood pressure (MAP) was measured in the brachial artery. 

The blood flow in the intestines and kidneys was measured using an ultrasonic blood flow meter at the mesenteric artery and renal artery. LSFG was used to measure the ocular blood flow. 

The mean blur rate (MBR), a blood flow index specific to LSFG, was measured in the retinal vessels and choroid. The rate of change of each parameter was compared with the baseline value before the blood was removed.

The investigators found that the MBR in the retinal vessels and choroid, the intestinal and renal blood flow, and the MAP decreased significantly as the blood was removed and recovered nearly to the baseline value when the blood was returned. 

The rates of change at the end of the period of blood removal were as follows: MAP, 69.4%; kidney, 43.5%; intestine, 54.8%; MBR of the retinal vessels, 42.3%; and MBR of the choroid, 55.5%.

The rates of change between the MBR of the retinal vessels and kidney and between the MBR of the choroid and intestine were similar, and no significant difference was observed. 

The MBR of the retinal vessels and MBR of the choroid were significantly positively correlated with the MAP (r = 0.87, 0.73), renal blood flow (r = 0.66, 0.59), and intestinal blood flow(r = 0.84, 0.61).

“In this study, the ocular blood flow reflected the blood flow in the kidneys and intestines,” the authors concluded. “The key takeaway point is that non-invasive ocular blood flow measurement using LSFG may be a new indicator of shock-related organ damage.”

This article is adapted from Watanabe’s presentation at the Association for Research in Vision and Ophthalmology 2021 virtual annual meeting. He has no financial interest in this subject matter.

Non-invasive ocular blood flow measurement using laser speckle flowgraphy may be a new indicator of shock-related organ damage, investigators report. 

Researchers target ocular blood flow, systemic organ blood flow in hemorrhagic shock

Dr Christopher Starr of Weill Cornell Medicine, discusses an overview of his virtual ARVO 2021 presentation regarding dry eye disease flares, including a rapid readout assessment of 10 years' worth of world literature to analyze studies in which the inflammatory disease's condition are categorized.

Dr Christopher Starr discusses key points from his virtual ARVO 2021 presentation regarding dry eye disease flares, including a rapid readout assessment of 10 years' worth of world literature to analyze studies in which the inflammatory disease's condition are categorized.

Looking at 10 years of dry eye disease flares

Dr. Michael Mbagwu, of the VA Palo Alto Health Care System; Byers Ophthalmic Innovations Fellow, Byers Eye Institute, Stanford University Medical School, speaks on the highlights of his virtual 2021 ARVO presentation regarding the development of an algorithm tool that links patient imaging to their clinical data, specifically within the American Academy of Ophthalmology's (AAO) IRIS Registry. 

Dr. Michael Mbagwu speaks on the highlights of his virtual 2021 ARVO presentation regarding the development of an algorithm tool that links patient imaging to their clinical data, specifically within the AAO IRIS Registry.  

Linking patient imaging to AAO IRIS Registry clinical data

Dr Theodore Leng medical advisor at Verana Health and director of clinical translational research, Byers Eye Institute, Stanford University School of Medicine, discusses the highlights from his presentation on "AAO IRIS Registry Data Replicates VIEW 1 and VIEW 2 Clinical Trial Outcome Data," in which the first replications using real-world data of a phase 3 trial was utilized, during the virtual 2021 ARVO meeting. 

Dr Theodore Leng discusses the highlights from his presentation on "AAO IRIS Registry Data Replicates VIEW 1 and VIEW 2 Clinical Trial Outcome Data," during the virtual 2021 ARVO meeting. 

Looking at real-world trial data replication outcomes of AAO IRIS Registry data 

Dr. Daniel F. Kiernan, a vitreoretinal surgeon at The Eye Associates, Sarasota, Florida, discusses the highlights of his 2021 ARVO virtual presentation on the effect of dexamethasone intracameral drug-delivery suspension on macular thickness based on optical coherence tomography (OCT) testing following vitreoretinal surgery.

Dr. Daniel F. Kiernan discusses key findings of a clinical study analyzing the effect of dexamethasone intracameral drug-delivery suspension on macular thickness based on OCT testing following vitreoretinal surgery.

Clinical results analyze dexamethasone implant effect on macular thickness

In order to improve patient care, guidelines for clinical and therapeutic management should be based on high quality scientific evidence, such as the fifth edition of the European Glaucoma Society guidelines,

 which contains only references from high quality systematic reviews, landmark 

 trials and population-based studies. Randomised controlled trials (RCTs) are one the most reliable sources of this type of evidence because, if well conducted, they can produce unbiased and generalisable data on diagnosis and therapy, giving fundamental insights into patient management.

Precision management to revolutionise glaucoma diagnosis and treatment

The Early Manifest Glaucoma Trial (EMGT) and the United Kingdom Glaucoma Treatment Study (UKGTS) are two prospective RCTs comparing treatment versus no treatment in glaucoma patients. Taken together, the results from these trials help us to answer the question of what we should do after diagnosing glaucoma in a patient.

The EMGT investigated the effects of medical treatment and laser treatment on glaucoma progression. Two hundred and fifty-five patients were recruited between 1993 and 1997 on a population-screening basis and followed until 2013.

Previously untreated glaucoma patients with repeatable visual field (VF) defect and corresponding optic nerve damage in at least one eye were enrolled, including those with primary open-angle glaucoma (POAG), normal tension glaucoma (NTG) and pseudo-exfoliative (PXF) glaucoma. Patients with advanced VF damage and high intraocular pressure (mean IOP >30 mmHg or IOP >35 mmHg in at least one eye) were excluded.

Participants were randomly allocated to treatment or no treatment. Treatment consisted of a combination of laser trabeculoplasty and topical betaxolol. The primary outcome was glaucoma progression, measured quantitatively by VF deterioration or optic nerve head changes. Mean baseline IOP was 20.7 mmHg and VF mean deviation (MD) was −4.7 dB.

The IOP trend during follow-up was different between the two groups. In the treated arm, IOP decreased from 20.6 to 15.5 mmHg at 3 months, corresponding to a 25% reduction from baseline; this was maintained throughout the follow-up period. No IOP changes were observed in the untreated arm.

Survival analysis showed that the differences in VF progression between groups arose early and were maintained for the entire follow-up period. Progression was more frequent in the control group at any time point, occurred earlier in controls and increased over time in both arms.

The first analysis (in 2001) showed significantly differently progression in the two groups: 62% in the control group and 45% in the treatment group.

 At the end of the study, progression was detected in 59% of treated participants compared with 76% of control participants, with a hazard ratio of 0.6.

An IOP of >21 mmHg, PXF syndrome, glaucoma in both eyes, worse median baseline MD and older age were significantly associated with risk of progression. Among the longitudinal factors, progression was strongly associated with the magnitude of initial IOP change, IOP at 3 months of treatment and mean IOP during follow-up.

 Disc haemorrhages and lower central corneal thickness (CCT) were also associated with risk of progression but the latter only in patients with higher baseline IOP.

Study examines pairing phacoemulsification with implantation of stents

Alongside the valuable data about the impact of treatment on glaucoma progression gained from this study, the untreated group allowed us to follow the natural course of the disease. By analysing data from untreated patients who were followed for at least 6 years, Heijl et al. showed that the majority of subjects experienced minimal yearly IOP changes, with larger IOP changes in those with PXF glaucoma.

 Overall, IOP did not increase in the untreated arm and 68% of patients showed glaucoma progression.

Rate of progression, as well as median time to progression, was higher in patients with PXF syndrome, followed by high tension glaucoma and NTG (−3.13 dB/year compared with −1.31 dB/year in high tension glaucoma and −0.36 dB/year in NTG).5 Accordingly, PXF glaucoma has a higher risk of progression if untreated.

The United Kingdom Glaucoma Treatment Study

The UKGTS was conducted in 2014. It was designed to have several similarities to the EMGT (e.g., inclusion criteria), to make the results as comparable as possible. The UKGTS was the first multicentre RCT to evaluate treatment with latanoprost (Xalatan, Pfizer) 0.005% versus placebo in glaucoma patients (POAG, NTG and PXF glaucoma).

Patients were enrolled consecutively between 2007 and 2010 and the primary outcome was VF deterioration within 24 months. Such a short observational period was possible because the frequency interval of VF was clustered at the beginning and the end of the trial, to maximise the power to detect progression.

As in EMGT, enrolled subjects had newly diagnosed and untreated glaucoma, defined by VF defect and corresponding damage to the optic nerve head. Patients with moderate-to-advanced VF damage were excluded, as well as those with elevated IOP (>35 mmHg on two consecutive occasions in either eye or mean baseline IOP of ≥30 mmHg).

Mean IOP was 20.1 mmHg and 19.6 mmHg in the placebo and treated group, respectively. The median MD at baseline was 2.9 dB, which means the glaucoma tended to be at an earlier stage than in the EMGT (median EMGT MD was −4.1 dB).

Mean IOP reduction from baseline was 5 mmHg (20%) in the treated group and 1.4 mmHg in the placebo group. The strongest initial response was slightly reduced at 6 months and then remained stable during the rest of the study.

At 24 months, the percentage of patients who reached the primary endpoint was significantly different between arms: 25.6% of patients in the placebo group compared with 15.2% in the treatment group. Time to deterioration was also significantly longer in the treated group with consequently longer VF preservation and a hazard ratio of 0.44. These differences were already evident at 12 and 18 months.

Is low vitamin D a risk factor for primary open angle glaucoma?

Increased risk of progression was associated with treatment allocation, glaucoma in both eyes, higher mean baseline IOP and disc haemorrhages at the baseline visit. History of heart attack and smoking habits were associated with risk of progression. Unlike in EMGT, age, CCT and severity of VF loss were not associated with risk of progression.

By combining the results from EMGT and UKGTS, common conclusions can be drawn and translated to clinical practice. Lowering IOP is effective in reducing disease progression in previously untreated patients with POAG, NTG and PXF glaucoma; the treatment’s efficacy depends on the patient’s pre-treatment IOP, with a stronger effect on higher baseline IOP values.

The rate of reduction is also crucial: each mmHg of IOP reduction decreases the risk of progression by a specific percentage. The lower the IOP reached—not only immediately after starting therapy but also during follow-up—the better the outcome.

When we analyse the results from RCTs, the statistical variability of data must be taken into account. We strongly need summary measures to draw overall conclusions and mean values of different parameters (such as mean annual IOP change, mean MD change, mean rate of progression), which represent the average behaviour of all participants, are usually reported.

However, there is a certain amount of variability around this value, corresponding to participants who have shown results that differ from the mean. Translating this statistical variability into clinical practice means that one must remember that any patient could be near the average or could be an outlier, showing a different behaviour from that expected, with regard to IOP changes, rate of progression and other parameters.

The EMGT and UKGTS trials provided extensive information on the natural history of glaucoma. When we look at survival analysis, we generally focus on differences between treated subjects and controls, but it also shows patients who progress despite treatment and controls who do not progress despite remaining untreated.

In the UKGTS, two-thirds of participants in the placebo group showed no VF deterioration during 24 months of follow-up and the same happened in 38% of untreated patients in EMGT.

 This suggests that patients with slight VF loss at baseline could be followed without treatment for a period. Then it becomes critical to assess the risk of progression of each patient, keeping in mind that the pattern could be difficult to predict and that the rate of progression may change over the period of observation.

In summary, besides stressing the importance of IOP reduction in preventing glaucoma progression, EMGT and UKGTS have shown that different factors affect the risk of disease progression. Looking for a particular target IOP or percentage IOP reduction is not the best option for all glaucoma subjects. Each patient must be considered as unique; only by quantifying the individual risk will it be possible to best tailor the treatment approach for each patient.

2. Heijl A, Leske MC, Bengtsson B, et al. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. 

3. Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. 

4. Leske MC, Heijl A, Hyman L, et al. Predictors of long-term progression in the early manifest glaucoma trial. 

5. Heijl A, Bengtsson B, Hyman L, et al. Natural history of open-angle glaucoma. 

Garway-Heath DF, Crabb DP, Bunce C, et al. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. 

Lascaratos G, Garway-Heath DF, Burton R, et al. The United Kingdom Glaucoma Treatment Study: a multicenter, randomized, double-masked, placebo-controlled trial: baseline characteristics. 

Dr Michelessi is a researcher at the Glaucoma Research Unit of the G.B. Bietti Foundation, Rome, Italy. Dr Giammaria is a research fellow in the Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Canada. Neither author reports any conflict of interest relevant to the subject matter.

Two randomised controlled trials, EMGT and UKGTS, have examined the factors affecting the risk of glaucoma progression. Global target IOPs are not the best option for all patients.

Using pivotal study data to guide glaucoma patient management decisions

Johnson + Johnson Vision announced today it is kicking off the availability of its TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the treatment of 

 allows for high-quality vision at both intermediate and far distances

 and is specifically engineered for rotational stability.

 The lens allows patients to achieve significantly improved intermediate vision, compared with a standard aspheric monofocal IOL, along with 20/20 distance vision.

According to Filomena Ribeiro, MD, PhD, FEBO, head director of ophthalmology at Hospital da Luz in Lisbon, Portugal, the haptic design and rotational stability of the TECNIS Eyhance Toric II IOL, has allowed her to offer her patients immediate improvements in their functional vision, while also correcting their astigmatism.

“Having implanted the TECNIS EyhanceToric II IOL, I can confidently say that this IOL is a game-changer in the monofocal category and in helping my patients get back to spending more time doing what they love,” she said in a statement.

Posterior corneal elevation: Is there a role for premium IOLs?

A survey of 17 leading European ophthalmologists found that their patients were satisfied with the lens.

 Meanwhile, more than 79% perceived their patients as being very satisfied with their intermediate and distance vision.

Additionally, 94% of those surveyed were very satisfied with the handling while implanting the lens, while nearly two thirds rated the overall performance of the lens as excellent compared to other toric IOLs.

 More than 80% also rated the rotational stability of the lens as excellent compared to other toric IOLs. All those surveyed said they were very likely to continue to use the lens in the future.

Ray tracing and IOL modelling in AMD patients

Erin McEachren, regional vice president, EMEA, Johnson + Johnson Surgical Vision, said the rollout offers the benefits of its most advanced monofocal IOL to cataract patients with astigmatism.

“It is an important first in Europe for the monofocal IOL category, as today most lenses in this category only correct vision to help patients with cataracts see things at a distance, and therefore do not improve the intermediate vision that is required for many important daily tasks,” McEachren said in a statement. “This is another breakthrough in meeting the ever-changing and evolving needs of our patients across Europe and the world.”

DOF2018CT4015 – Clinical evaluation of the TECNIS Eyhance Model ICB00 – 6-month clinical study. Sep 2018. Based on a clinical study, N=134 achieved mean 20/20 monocular pooled distance BCDVA.

TECNIS Eyhance Toric II IOL – Survey of 17 surgeons about experiences with DIU. May 2021. REF2021CT4156.

According to the company, more than 400 eyes of patients from 12 European countries have been fitted with the TECNIS Eyhance Toric II IOL, with surgeons surveyed noting that their patients are pleased with the results. 

Johnson + Johnson's TECNIS Eyhance Toric II IOL launches in Europe

 have a very high-tech and sophisticated optical system that works excellently when the cornea is in perfect condition. Therefore, they are contraindicated in patients who have corneal haze, scar or oedema.

A patient who has a posterior corneal elevation is susceptible to higher-order aberrations (HOAs) or early keratoconus. Consequently, many surgeons will refrain from using premium IOLs in such cases. As one of the first surgeons in Saudi Arabia to use a trifocal lens, I meticulously select my patients.

In Saudi Arabia, keratoconus is prevalent due to the dry atmosphere, seasonal allergies and consanguinity. However, not all patients have the same severity of disease. Some patients live their entire lives without knowing that they have keratoconus or without signs of the condition. Others present early with signs and symptoms.

Ray-tracing and IOL modeling in AMD patients

Many patients who present to me with the desire to be spectacle-free have questionable corneal tomography images. The first keratoconus patient I treated with a trifocal lens (AT LISA tri toric 939 M/MP; Carl Zeiss Meditec) was one of my colleagues, a 52-year-old physician with a mild but stable form of keratoconus.

Her central cornea seemed to be normal and the steepening was at the inferior part of the cornea, sparing the central 5-mm zone. The HOA at the 6-mm zone was 1.2 μm, outside the normally accepted range of up to 0.5 μm.

The patient was keen to try trifocal lenses, so after long discussion and counselling the procedure was undertaken. Postoperatively, she was incredibly happy, with uncorrected visual acuity 6/6 at near, distance and intermediate. She had no visually disturbing aberrations.

I then performed the same procedure on her sister, who suffers from subclinical keratoconus, and who also responded very well. That is when I began to consider premium IOLs for certain cases of keratoconus patients. I developed my own criteria for selection and, so far, patients have been very satisfied.

How to use topography-guided laser procedures to treat keratoconus

I have performed this procedure on four patients (eight eyes) with different categories of keratoconus but who all share one thing in common – the central 5-mm zone with an accepted range of HOA. It is not extremely high, but it is apparent that they do not have a normal posterior cornea.

During diagnosis, all patients undergo a routine, complete ophthalmic examination, which includes dry and wet refraction. Patients also undergo a meticulous clinical assessment and detailed history-taking, including family history, previous trauma, allergies, any spectacles changes and the frequency of these changes, and contact lens use. Next, we perform corneal tomography, which is key for diagnosing keratoconus and precisely shows the anterior corneal curvature and the posterior corneal curvature.

Using four-maps analysis, I perform the Belin Ambrosio Enhanced Ectasia analysis and I study them carefully. Then I check the elevation maps, both in the forms of best-fit sphere and the best-fit toric ellipsoid.

I compare the maps and see if the patient has good spectacle correction. If the patient does not have high central aberration, I then consider implanting a trifocal lens.

I speak with the patients about HOA photic phenomena and explain that they should anticipate some glare and halos over time. I even show them a picture of what glare and halo will look like so that they know what to expect in the coming weeks. I also discuss mental adaptation and how their vision might be adapted to some aberration.

The good thing about keratoconus patients is that they are already used to a minimum amount of light, glare and halos. If their central vision is okay, it is not exaggerated by premium lenses. In all my cases, glare and halos have turned out to be benign; however, I still like to set realistic expectations.

Corneal crosslinking outcomes appear to justify its use in paediatrics

I perform a routine phacoemulsification and painstakingly centre the IOL. The plate haptic design IOL centres itself easily and this is a strong point in favour of this design.

I like to place one suture to be sure that the lens does not move, especially if ectatic corneas have delayed healing or might have microleaks and fluctuation in eye pressure, which can change the lens position. If the patient is receiving a toric lens, I ensure that the anterior chamber maintains its stability.

The postoperative regimen is similar to that of a routine phaco procedure. I examine the patient and remove the suture within the first week and no later than 2 weeks from surgery. Then I reassess the patient’s vision at 2 weeks, 6 weeks and 3 months.

One step of utmost importance is assuring the patient that the lens is removable if he or she is not happy. I offer patients a lens removal within the first 6 weeks if the aberration is higher than anticipated, and this provides some reassurance for the patient.

A 56-year-old breast cancer survivor with subclinical keratoconus wanted to treat herself after surviving her cancer by getting her eyesight back. She had heard about premium lenses and presented to me with a specific interest in trying them.

Considering her condition, I conducted an examination and determined that she was fine to move forward with the procedure. She told me that she was reborn after two things: recovering from breast cancer and being spectacle-free for the first time in her life.

A 48-year-old man in a sensitive diplomatic position presented to me and shared that his use of spectacles was causing some embarrassment because there are times when he was unable to wear them but still required to read things and he felt that this was disabling him. He was considering leaving his job due to his inability to focus.

He had posterior corneal elevation. The procedure was successful, and he has returned to work without anyone knowing that he had undergone the procedure.

Sometimes, surgeons can be afraid of technology because we do not know what is hidden behind it, and we refrain from exploring new advancements because we do not want our patients to have an unsatisfactory experience.

Given my recent experience with implanting premium lenses in challenging cases, I have changed my perspective and now view these opportunities as another way to give my patients a chance. With the confidence that I can exchange the lens with minimum complications as a backup plan and considering that there is no cost to the patient because I work in a government hospital, I have to ask myself why not.

In the end, the keratoconus patients who have received premium lenses are the happiest patients I have. This is probably because they are used to some amount of HOA so they adapt to their new IOLs faster and have higher tolerance than people with normal eyes.

Dr Al Saati is chief of the Anterior Segment Division at Prince Sultan Military Medical City, Riyadh, Saudi Arabia. She has no financial disclosures to make regarding any of the lenses used in this case series.

It is widely accepted that patient selection is the key to success with premium IOLs. However, with care, premium IOLs can be implemented in challenging cases.