Vision Improvement for Patients With Age-Related Macular Degeneration

NCT04268836 | Unknown

• 1 other identifier: OAC #001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision for patients with age-related macular degeneration.

Conditions

Age-related Macular Degeneration

Keywords

dry AMD; wet AMD; neovascular AMD; age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx

  CDVA will be measured using ETDRS letter scoring both pre-Tx and post-Tx with follow-up to 24 months post-Tx

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• Visual Function Questionnaire (VFQ)-25 quality of life assessment

  Through study completion, an average of 2 years

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System.

Device: Optimal Acuity Clear-K® Low Vision Aid System treatment

Interventions

Optimal Acuity Clear-K® Low Vision Aid System treatment DEVICE

The treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change.

Treatment arm

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Any race
• Patient is at least 50 years old.
• Patient has diagnosed dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination by a retina specialist; the full ocular examination, including optical coherence tomography (OCT) measurements, should be part of the patient's file.
• Wet AMD eyes should have an inactive disease state (i.e., there is no clinical or OCT evidence of wet AMD disease activity).
• Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated..
• Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
• Patient has moderate to severe vision impairment due to dry age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20/80 or worse (decimal = 0.25 or less; logMAR ≥ 0.60) in the better eye.
• Patient has CDVA of 20/400 or better (decimal = 0.05 or greater; logMAR ≤ 1.30) in the worse eye.
• Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires) in both eyes.
• Patient is not a contact lens (CL) wearer.
• Patient is willing and able to comply with all examinations.
• Patient must be competent to sign an informed consent form before study entry.

You may not qualify if:

• Corneal disease or disorder in either eye;
• Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone);
• Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola (as evaluated by optical coherence tomography);
• Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA;
• Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma; and
• Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.

Sponsors & Collaborators

• Optimal Acuity Corporation: lead
• Bochner Eye Institute: collaborator

Study Sites (1)

1929 Bayview Ave., Suite 117

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Michael Berry, PhD

  Optimal Acuity Corporation

  STUDY DIRECTOR

Central Study Contacts

Michael Berry, PhD

CONTACT

8318691384; mberry177@gmail.com

Samuel Markowitz, MD, FRCSC

CONTACT

4165315425; snm1@rogers.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, unmasked clinical study

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 13, 2020
• Study Start: January 9, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 1, 2025
• Last Updated: March 22, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)