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

NCT04984590 | Completed Results

• 1 other identifier: IOPCL AMD-20
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Vision; Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• Tilt of the PCIOL and IOPCL MAG Complex

  Measuring postoperative tilt of the PCIOL and IOPCL MAG complex. Tilt was defined as less than or equal to 10 degrees.

  12 Months

• IOPCL MAG Decentration

  Measures the decentration of the IOPCL MAG against the PCIOL. Decentration was defined as the horizontal and vertical distances greater than or equal to 0.25mm or less than or equal to 0.75mm.

  12 Months

• Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)

  Proportion of eyes (≥ 75%) able to achieve improvement of 10 letters or more of uncorrected near visual acuity (at 14 cm) at 12 months from baseline

  12 Months

Secondary Outcomes (5)

• Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)

  12 months

• Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)

  12 months

• Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)

  12 months

• Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)

  12 months

• Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)

  12 months

Study Arms (1)

IOPCL AMD MAG

OTHER

All subjects will receive a 10.0 Diopter intraocular pseudophakic capsular lens magnifier (IOPCL MAG)

Device: IOPCL AMD MAG

Interventions

IOPCL AMD MAG DEVICE

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.

IOPCL AMD MAG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 55 years or older.
• Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a lens power between 17.0 diopters and 24.0 diopters clearly evidenced by photographic documentation by one of the following:
• patient medical record
• clinic chart with labeling attached
• surgical record with labeling attached, or
• patient identification card with make, model and serial number.
• Subjects who have already had cataract surgery at least 6 months from the planned date of the IOPCL surgery.
• Subjects who have had a Nd: YAG capsulotomy at least 1 month prior to the planned date of the IOPCL surgery.
• Subjects with non-neovascular dry AMD meeting the following criteria:
• No change in Amsler Grid test within the past 12 months
• No subretinal fluid or macular hemorrhage confirmed by optical coherence tomography (OCT) imaging.
• No fundoscopic changes within the past 12 months (i.e., changes in retinal pigment epithelium).
• Subjects with best corrected distance visual acuity from 20/80 to 20/800.
• Subjects with a preoperative manifest refraction spherical equivalent (MRSE) of +1.0D to -1.0D.
• Subjects with ≤1.0D of corneal cylinder determined by keratometry readings.

You may not qualify if:

• Subjects who have already had cataract surgery with a toric or multifocal or accommodating Intraocular Lens.
• Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a power below 17.0 diopters and greater than 24.0 diopters.
• Subjects with neovascular (wet) AMD.
• Subjects who have not had an Nd: YAG capsulotomy.
• Subjects who were treated with an IOL off-label.
• Subjects who have more than 1.0D of corneal cylinder determined by Keratometry readings.
• Subjects whose continuous curvilinear capsulorhexis was less than 5mm or more than 6.0 mm in size at the time of IOL surgery.
• Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
• Subjects with anterior capsule fibrosis and phimosis that in the opinion of the investigator may confound the outcome or increase the risk to the subject.
• Subjects who do not gain at least 10 letters of near visual acuity with the simulation/tolerance testing (using manifest refraction with +7.0D add) compared to conventional near vision testing (using manifest refraction with +3.0D add).
• Subjects with a concomitant retinal or choroidal disorder other than AMD.
• Subjects with any corneal abnormality, other than regular corneal astigmatism that in the opinion of the investigator would confound the outcome(s) of the study.
• Subjects with clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
• Subjects with microphthalmos.
• Subjects with a previous retinal detachment.

Sponsors & Collaborators

• OnPoint Vision Inc: lead

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Conditions

Vision, Low; Macular Degeneration

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Results Point of Contact

• Title: Head of Clinical
• Organization: OnPoint Vision Inc.

larcher@onpoint-vision.com

949-688-0660

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment with IOPCL AMD MAG at least 6-months after cataract surgery with Alcon Model SN60WF or SA60AT

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 30, 2021
• Study Start: January 21, 2022
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: January 31, 2025
• Results First Posted: November 19, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)