Vision Improvement for Legally Blind Dry AMD Patients

NCT04875234 | Not Yet Recruiting

• 1 other identifier: Retro3
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.

Conditions

Dry Age-related Macular Degeneration; Vision Impairment and Blindness

Keywords

AMD, vision impairment, blindness

Outcome Measures

Primary Outcomes (1)

• Best spectacle-corrected distance visual acuity (BCDVA)

  BCDVA measured using ETDRS eye charts

  12 months post-treatment

Study Arms (1)

Legally Blind Dry AMD Patients

Legally Blind Dry AMD Patients with either unilateral or bilateral blindness

Device: Clear-K Low Vision Aid Treatment

Interventions

Clear-K Low Vision Aid Treatment DEVICE

A Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina.

Legally Blind Dry AMD Patients

Eligibility Criteria

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

Study Population

Patients with dry age-related macular degeneration an legal blindness in one or both eyes

You may qualify if:

• Male or Female
• Any race
• Patient is at least 50 years old.
• Patient must have dry AMD in the study eye.
• Patient is legally blind due to AMD - i.e., has corrected distance visual acuity (CDVA) of 20/125 or worse (45 letters; logMAR ≥ 0.80) in the study eye.
• Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires).
• Patient is not a contact lens 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:

• Visually significant cataract in the study eye
• Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
• Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
• Previous corneal surgery in the study eye
• 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 may confound the outcome of the study

Sponsors & Collaborators

• Optimal Acuity Corporation: lead

MeSH Terms

Conditions

Vision Disorders; Blindness

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Berry, PhD

  Optimal Acuity Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Berry, PhD

CONTACT

831-869-1384; mberry177@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 22, 2023

Record last verified: 2022-04