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

Primary Purpose

Age-related Macular Degeneration

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Optimal Acuity Clear-K® Low Vision Aid System treatment

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring dry AMD, wet AMD, neovascular AMD, age-related macular degeneration

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

1929 Bayview Ave., Suite 117

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT04268836

First Posted

January 16, 2018

Last Updated

March 21, 2023

Sponsor

Optimal Acuity Corporation

Collaborators

Bochner Eye Institute

1. Study Identification

Unique Protocol Identification Number

NCT04268836

Brief Title

Vision Improvement for Patients With Age-Related Macular Degeneration

Acronym

AMD

Official Title

Vision Improvement for Patients With Age-Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 9, 2024 (Anticipated)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Optimal Acuity Corporation

Collaborators

Bochner Eye Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, non-randomized, unmasked clinical study

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Optimal Acuity Clear-K® Low Vision Aid System treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Through study completion, an average of 2 years

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Through study completion, an average of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Berry, PhD

Phone

8318691384

mberry177@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Samuel Markowitz, MD, FRCSC

Phone

4165315425

snm1@rogers.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Berry, PhD

Organizational Affiliation

Optimal Acuity Corporation

Official's Role

Study Director

Facility Information:

Facility Name

1929 Bayview Ave., Suite 117

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samuel Markowitz, MD, FRCSC

Phone

4165315425

snm1@rogers.com

First Name & Middle Initial & Last Name & Degree

Samuel N Markowitz, MD, FRCSC

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Vision Improvement for Patients With Age-Related Macular Degeneration

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