First Results of a New Hyperaspheric Add-on Intraocular Lens Approach Implanted in Pseudophakic Patients with Age-Related Macular Degeneration

Fritz H Hengerer; Gerd U Auffarth; Scott J Robbie; Timur M Yildirim; Ina Conrad-Hengerer

doi:10.1016/j.oret.2018.02.003

First Results of a New Hyperaspheric Add-on Intraocular Lens Approach Implanted in Pseudophakic Patients with Age-Related Macular Degeneration

Ophthalmol Retina. 2018 Sep;2(9):900-905. doi: 10.1016/j.oret.2018.02.003. Epub 2018 Mar 22.

Authors

Fritz H Hengerer¹, Gerd U Auffarth², Scott J Robbie³, Timur M Yildirim², Ina Conrad-Hengerer²

Affiliations

¹ Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. Electronic address: [email protected].
² Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.
³ Department of Ophthalmology, St. Thomas' Hospital, London, United Kingdom.

PMID: 31047222
DOI: 10.1016/j.oret.2018.02.003

Abstract

Purpose: To determine the visual outcomes of the EyeMax Mono intraocular lens (IOL) technology (London Eye Hospital Pharma, London, UK), which is a foldable and injectable hydrophobic acrylic IOL implanted as an add-on solution in pseudophakic eyes with age-related macular degeneration, in a pilot study.

Design: A prospective, interventional case series.

Participants: A total of 22 pseudophakic eyes (11 patients) with bilateral severe or intermediate dry age-related macular degeneration (AMD) (13 eyes) or stable wet AMD or disciform scarring (9 eyes) meeting the criteria for sulcal IOL implantation.

Methods: Both eyes of participating subjects underwent small-incision ciliary sulcal implantation of a hyperaspheric, soft hydrophobic acrylic intraocular lens designed to improve the quality of the retinal image in all areas of the macula ≤10° from fixation and to generate a moderate hypermetropic correction for magnification.

Main outcome measures: The primary outcome was safety as determined by intra- and postoperative complications, raised intraocular pressure requiring medical or surgical intervention, postoperative diplopia, reduction in visual field, and loss of ≥2 lines of visual acuity. Secondary outcomes were improvements in subjective and objective visual acuity (logarithm of the minimum angle of resolution).

Results: No intraoperative complication occurred. Elevated intraocular pressure values were measured directly after the operative procedure in 2 eyes (25 mmHg and 27 mmHg) and at the 1-week postoperative visit in 1 eye (22 mmHg) but not later. The mean postoperative spherical equivalent of refraction changed to +2.5 diopters, and all eyes had gained ≥2 lines of visual improvement (corrected distance visual acuity) by 6 months after surgery. Corrected near visual acuity as well as corrected distance visual acuity improved over time, suggesting a neuroadaptive component to improved visual function with the device. Devices were implanted bilaterally in all patients, and there were no reported symptoms of dysphotopsia or diplopia.

Conclusions: Safety concerns were not identified in the short-term or medium term. These results indicate the potential of the EyeMax Mono IOL to improve near and distance visual acuity in pseudophakic eyes with intermediate to severe AMD.