NCT04984590

Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects

Early Feasibility Study to Evaluate the Safety and Effectiveness of the Intraoperative Pseudophakic Capsular Lens Magnifier for Age-Related Macular Degeneration (IOPCL AMD-MAG) for Secondary Implantation in the Capsular Bag to Improve Near Vision in Subjects With Age-Related Macular Degeneration After Cataract Surgery

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: OnPoint Vision Inc · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

This early feasibility study aims to improve near vision in subjects 55 years or older who have a clinical diagnosis of Age-Related Macular Degeneration. Subjects must have previously been implanted with either the Alcon Model SN60WF or Model SA60AT intraocular lens at least 6-months prior to receiving the IOPCL (intraocular pseudophakic capsular lens). Subject will be followed for a period of 12-months.

Detailed description

This will be a 12-month study, in which a maximum of 10 pseudophakic subjects from up to three clinical sites with a diagnosis of age-related macular degeneration will be enrolled. The IOPCL MAG (intraocular pseudophakic capsular lens magnifier) consists of a 4.5mm diameter optic. The IOPCL MAG is centered above the existing intraocular lens. The IOPCL MAG is designed to improve near vision of the AMD subject by providing magnification of 10 diopters in the central 1.8mm zone of the lens optic. The primary objective of this study is to determine the stability of the IOPCL-AMD-MAG to successfully adhere to a pseudophakic intraocular lens (PCIOL) without slippage or rotation. The secondary objective of this study is to determine if the IOPCL-AMD-MAG can improve uncorrected near vision in subjects previously implanted with the Alcon Models SN60WF or SA60AT. Outcome simulation testing will be performed prior to the subject receiving the IOPCL. To qualify for the study the subject must demonstrate an improvement in uncorrected near visual acuity of 10 letters over baseline.

Conditions

• Low Vision
• Age Related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	IOPCL AMD MAG	The IOPCL MAG (intraocular pseudophakic capsular lens magnifier) consists of a 4.5 mm diameter optic. The central 1.8mm of the anterior surface has a power of 10.0 diopters. This IOPCL MAG will be implanted over an Alcon Model SN60WF or SA60AT intraocular lens to improve near vision.

Timeline

• Start date: 2022-01-21
• Primary completion: 2024-03-20
• Completion: 2024-03-20
• First posted: 2021-07-30
• Last updated: 2025-01-31
• Results posted: 2024-11-19

Locations

1 site across 1 country: United States