An implantable option bridges the gap for patients with AMD

Age-related macular degeneration (AMD) casts a shadow of blindness over millions of lives worldwide: 288 million people are expected to be affected by 2040.¹ In the United States alone, 2% to 3% of those over age 50 are already impacted.² The impact extends beyond lost vision, with profound emotional, social and economic consequences including decreased independence, reduced quality of life and incidences of depression.

Figure. Change of CDVA and CNVA From Baseline to Last Follow-Up.
CDVA, corrected distance visual acuity; CNVA, corrected near visual activity.

(Graph courtesy of Clinical Ophthalmology)

In individuals diagnosed with AMD, a remarkable compensatory mechanism emerges to mitigate the detrimental effects of central vision loss. It involves the utilisation of a preferred retinal locus (PRL), a location within the macula, outside the foveal region, which serves as the primary site for visual perception in the absence of foveal function. However, this novel visual pathway comes at the cost of compromised visual acuity, as the PRL does not replicate the same quality of vision afforded by the fovea, resulting in a noticeable reduction in visual clarity and definition.³ Despite this trade-off, the establishment of a PRL represents a vital means of preserving some visual function in individuals with AMD, offering a measure of resilience in the face of progressive vision loss.

In order to restore vision for those affected by central vision loss, proposed solutions have included implantable devices and intraocular telescopes. While these advancements have shown promise, they have some drawbacks: cumbersome surgeries, limited field of vision and the need for intense rehabilitation training.^4,5 The status quo—standard monofocal IOLs when cataract surgery is required—may offer temporary improvement of vision, but ultimately fall short, as they exacerbate the very issue by tightly focusing light on the diseased fovea.^6,7

The optical design for improving vision in AMD

An extended macular vision (EMV) IOL is a lens that has been specifically developed to address the distinct challenges of dry AMD. By employing advanced optics to enhance image clarity across the entire macula, this device is designed to enable patients with retinal pathologies to make better use of a PRL, thereby improving their visual function without extensive rehabilitation.

At our facility in Milan, we have adopted the use of the EyeMax Mono IOL (Sharpview Ophthalmology) to address the unique visual needs of patients with dry AMD and retinal diseases in general. This clinical experience formed the basis for our recently published peer-reviewed study in Clinical Ophthalmology, in which we present our long-term safety and sustained visual results in eyes with macular disease and visually insignificant cataract.⁸

This extended macular vision IOL is specifically designed to revitalise image quality in areas of the retina that may still be unaffected by disease. Its optical design allows the light to focus across the entire 10 degrees of the macula unlike the standard IOL or even the crystalline lens that focus the image on the central 4 degrees only, an area that is often compromised by the retinal condition.⁹ Besides the different optical design, it is a standard monofocal IOL, which requires no modification to standard cataract surgery technique, using the same incision size, injector system and surgical approach. As such, it shares the same safety profile of standard monofocal IOLs (note that the EyeMax Mono is CE-marked and not yet approved in the United States as of May 2025).

The study: Long-term benefits of EyeMax Mono IOL in AMD

We conducted a study that uniquely targeted 113 eyes with visually insignificant cataracts and intermediate to severe AMD (of which 9.7% of eyes were developing extensive atrophy) to evaluate the long-term efficacy and safety of the EMV IOL with a mean follow-up period of 48.3 months.⁸ Nearly 95% of participants gained at least one line of corrected distance visual acuity (CDVA), with 35% experiencing a three-line improvement (Figure). Notably, even eyes with extensive maculopathy, a condition previously deemed unresponsive to treatment, demonstrated a significant increase in CDVA (0.32 logMAR improvement). The study’s findings also showed that the visual gains persisted even after several years, with participants followed up for as long as 9 years still experiencing significant improvements.

Indeed, beyond the immediate observable outcomes, this EMV IOL potential is more fully realised in its long-term impact on patients’ visual function. While previous studies have elucidated its short-term efficacy and safety,^9-11 research indicates that the PRLs may require up to 6 months to fully develop. It is within this extended time frame that the optical design value may be demonstrated: a sustained and significant visual improvement, which can only be fully appreciated through longitudinal observation.

Interestingly, patients with poorer baseline vision experienced the most significant improvements, suggesting that the optical design helps maximise the use of remaining healthy areas in the macula. This makes it particularly valuable for individuals with advanced macular disease. No specific intraoperative or postoperative complications were reported, and vision loss was uncommon, affecting only 2.7% of eyes. This is a low rate given that these patients are inherently prone to vision deterioration due to the progressive nature of the disease.

However, it is crucial to emphasise this point: the EyeMax Mono does not cure AMD. Its value is in helping patients with AMD make better use of their remaining healthy retina, even in the presence of foveal atrophy. If macular atrophy reaches and covers the entire 10-degree central area, the benefits of the lens are eroded.

A second chance at sight: Rethinking AMD management

EMV IOL design has been shown to support the brain’s adaptation and the development of new visual pathways, in the face of retinal pathology progression. This is promising for younger patients who have had their central vision compromised by macular degeneration, offering a chance to regain some of the lost acuity. For instance, one remarkable case in our study was a patient diagnosed with AMD at a young age due to occupational sun exposure.¹² Over the course of more than 6 years following implantation, this individual’s vision not only stabilised, but significantly improved.

Recent advancements in EMV IOLs represent a significant development in the management of AMD. Unlike more invasive implantable devices or intraocular telescopes— which may be better suited for patients with profound vision loss but require complex surgery and rehabilitation—an EMV IOL offers a simple and safe alternative that can be used earlier in the disease course. It bridges the gap between conventional monofocal lenses and more advanced (and difficult-to-use and implant) solutions, by enhancing image quality across the macula and supporting the brain’s ability to adapt to central vision loss. While it does not halt disease progression, our long-term data suggest that it can deliver sustained visual improvements in selected patients with AMD, particularly those with preserved peripheral macular function. Further prospective studies will help define its role more precisely, but current evidence supports its utility as a practical and effective option for patients with dry AMD undergoing cataract surgery.

References

1. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-e116. doi:10.1016/S2214-109X(13)70145-1

2. Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008;358(24):2606-2617. doi:10.1056/NEJMra0801537

3. Crossland MD, Engel SA, Legge GE. The preferred retinal locus in macular disease. Retina. 2011;31(10):2109-2114. doi:10.1097/IAE.0b013e31820d3fba

4. Grzybowski A, Wasinska-Borowiec W, Alio JL, Amat-Peral P, Tabernero J. Intraocular lenses in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2017;255(9):1687-1696. doi:10.1007/s00417-017-3740-8

5. Dunbar HMP, Dhawahir-Scala FE. A Discussion of commercially available intra-ocular telescopic implants for patients with age-related macular degeneration. Ophthalmol Ther. 2018;7(1):33-48. doi:10.1007/s40123-018-0129-7

6. Kessel L, Erngaard D, Flesner P, Andresen J, Tendal B, Hjortdal J. Cataract surgery and age‐related macular degeneration. An evidence‐based update. Acta Ophthalmol. 2015;93(7):593-600. doi:10.1111/aos.12665

7. Casparis H, Lindsley K, Kuo IC, Sikder S, Bressler NM. Surgery for cataracts in people with age-related macular degeneration. Cochrane Database of Syst Rev. 2017; 2(2):CD006757. doi:10.1002/14651858.CD006757.pub4

8. Badalà F, Bona E, Devincenzi G, Nouri-Mahdavi K. Long-term visual outcomes of an extended macular vision IOL in eyes with macular disease and visually insignificant cataract. Clin Ophthalmol. 2024;18:2765-2775. doi:10.2147/OPTH.S481570

9. Robbie SJ, Tabernero J, Artal P, Qureshi MA. Initial clinical results with a novel monofocal-type intraocular lens for extended macular vision in patients with macular degeneration. J Refract Surg.2018;34(11):718-725. doi:10.3928/1081597X-20180831-01

10. Hengerer FH, Auffarth GU, Robbie SJ, Yildirim TM, Conrad-Hengerer I. First results of a new hyperaspheric add-on intraocular lens approach implanted in pseudophakic patients with age-related macular degeneration. Ophthalmol Retina. 2018;2(9):900-905. doi:10.1016/j.oret.2018.02.003

11. Qureshi MA, Robbie SJ, Hengerer FH, Auffarth GU, Conrad-Hengerer I, Artal P. Consecutive case series of 244 age-related macular degeneration patients undergoing implantation with an extended macular vision IOL. Eur J Ophthalmol. 2018;28(2):198-203. doi:10.5301/ejo.5001052

12. Sui GY, Liu GC, Liu GY, et al. Is sunlight exposure a risk factor for age-related macular degeneration? a systematic review and meta-analysis. Br J Ophthalmol. 2013;97(4):389-394. doi:10.1136/bjophthalmol-2012-302281

Federico Badalà, MD |E: direzione@microchirurgiaoculare.com

Badalà is an Italian ophthalmologist renowned for pioneering advanced surgical techniques in corneal transplantation, cataract surgery and macular treatments. He has trained in Italy and at the UCLA Stein Eye Institute in California. Dr Badalà practices in Milan at Micro Chirurgia Oculare.

Financial disclosure: Consultant to SharpView Ophthalmology