Vision Improvement for Legally Blind Dry AMD Patients

NCT ID: NCT04875234

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.

Conditions

Dry Age-related Macular Degeneration; Vision Impairment and Blindness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Legally Blind Dry AMD Patients

Legally Blind Dry AMD Patients with either unilateral or bilateral blindness

Clear-K Low Vision Aid Treatment

Intervention Type: 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.

Interventions

Clear-K Low Vision Aid Treatment

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Optimal Acuity Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Berry, PhD

Role: PRINCIPAL_INVESTIGATOR

Optimal Acuity Corporation

Central Contacts

Michael Berry, PhD

Role: CONTACT

mberry177@gmail.com

831-869-1384

Other Identifiers

Retro3

Identifier Type: -

Identifier Source: org_study_id