Vision Improvement for Patients With Age-Related Macular Degeneration (AMD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Device: Optimal Acuity Clear-K® Low Vision Aid System treatment

Detailed Description

The Optimal Acuity Clear-K® Low Vision Aid System treats corneas with near infrared light in order to change the modulus of small volumes of anterior stromal corneal tissue. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision.

200 AMD patients meeting eligibility requirements will be treated. The study will record and analyze pre-treatment (Tx) and post-Tx examinations with follow-up extending to 24 months post-Tx. Analysis will include descriptive statistics and measures of correlation between outcomes and patient baseline characteristics.

The primary objective of the study is to evaluate the safety and effectiveness of Clear-K® treatment in providing vision improvement to AMD patients.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Berry, PhD; Phone Number: 8318691384; Email: mberry177@gmail.com
• Study Contact Backup: Name: Samuel Markowitz, MD, FRCSC; Phone Number: 4165315425; Email: snm1@rogers.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3E8
      • 1929 Bayview Ave., Suite 117
      • Contact: Samuel Markowitz, MD, FRCSC; Phone Number: 4165315425; Email: snm1@rogers.com
      • Principal Investigator: Samuel N Markowitz, MD, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or Female
2. Any race
3. Patient is at least 50 years old.
4. 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.
5. Wet AMD eyes should have an inactive disease state (i.e., there is no clinical or OCT evidence of wet AMD disease activity).
6. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated..
7. Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
8. 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.
9. Patient has CDVA of 20/400 or better (decimal = 0.05 or greater; logMAR ≤ 1.30) in the worse eye.
10. Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires) in both eyes.
11. Patient is not a contact lens (CL) wearer.
12. Patient is willing and able to comply with all examinations.
13. Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria:

1. Corneal disease or disorder in either eye;
2. Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone);
3. 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);
4. Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA;
5. Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma; and
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System.	Device: Optimal Acuity Clear-K® Low Vision Aid System treatment; The treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Function Questionnaire (VFQ)-25 quality of life assessment	The VFQ-25 instrument will be used to assess patient quality of life measures.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Optimal Acuity Corporation
• Collaborators: Bochner Eye Institute
• Investigators: Study Director: Michael Berry, PhD, Optimal Acuity Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): January 9, 2024
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: age-related macular degeneration; wet AMD; dry AMD; neovascular AMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: OAC #001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No