Vision Improvement for Legally Blind Dry AMD Patients

Dry Age-related Macular Degeneration Clinical Trial

Official title:

Vision Improvement for Legally Blind Dry Age-Related Macular Degeneration Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875234
• Other study ID #: Retro3
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2022
• Source: Optimal Acuity Corporation
• Contact: Michael Berry, PhD
• Phone: 831-869-1384
• Email: mberry177[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

IInclusion 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

Related Conditions & MeSH terms

• Blindness
• Dry Age-related Macular Degeneration
• Macular Degeneration
• Vision Impairment and Blindness

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Optimal Acuity Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best spectacle-corrected distance visual acuity (BCDVA)	BCDVA measured using ETDRS eye charts	12 months post-treatment