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

• ClinicalTrials.gov Identifier: NCT04268836
• Recruitment Status: Not yet recruiting
• First Posted: February 13, 2020
• Last Update Posted: February 24, 2021
• Sponsor: Optimal Acuity Corporation
• Collaborator: Bochner Eye Institute
• Information provided by (Responsible Party): Optimal Acuity Corporation

Tracking Information

• First Submitted Date: January 16, 2018
• First Posted Date: February 13, 2020
• Last Update Posted Date: February 24, 2021
• Estimated Study Start Date: June 1, 2021
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2020)

Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx [ Time Frame: Through study completion, an average of 2 years ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 11, 2020)

Visual Function Questionnaire (VFQ)-25 quality of life assessment [ Time Frame: Through study completion, an average of 2 years ]

The VFQ-25 instrument will be used to assess patient quality of life measures.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vision Improvement for Patients With Age-Related Macular Degeneration
• Official Title: Vision Improvement for Patients With Age-Related Macular Degeneration
• 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.

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
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Prospective, non-randomized, unmasked clinical study

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Age-related Macular Degeneration

Intervention

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.

Study Arms

Experimental: Treatment arm

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

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: December 31, 2020): 200
• Original Estimated Enrollment (submitted: February 11, 2020): 120
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: September 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Michael Berry, PhD; 8318691384; mberry177@gmail.com

Contact: Samuel Markowitz, MD, FRCSC; 4165315425; snm1@rogers.com

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04268836
• Other Study ID Numbers: OAC #001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Optimal Acuity Corporation
• Study Sponsor: Optimal Acuity Corporation
• Collaborators: Bochner Eye Institute

Investigators

• Study Director: Michael Berry, PhD; Optimal Acuity Corporation

• PRS Account: Optimal Acuity Corporation
• Verification Date: December 2020