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Vision Improvement for Legally Blind Dry AMD Patients


Study First Submitted Date 2021-05-03
Study First Posted Date 2021-05-06
Last Update Posted Date 2023-03-22
Start Month Year January 2024
Primary Completion Month Year July 2025
Verification Month Year April 2022
Verification Date 2022-04-30
Last Update Posted Date 2023-03-22

Detailed Descriptions

Sequence: 20657599
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.


Sequence: 52004420 Sequence: 52004421
Name Dry Age-related Macular Degeneration Name Vision Impairment and Blindness
Downcase Name dry age-related macular degeneration Downcase Name vision impairment and blindness

Id Information

Sequence: 40028560
Id Source org_study_id
Id Value Retro3

Design Groups

Sequence: 55409718
Title Legally Blind Dry AMD Patients
Description Legally Blind Dry AMD Patients with either unilateral or bilateral blindness


Sequence: 52317126
Intervention Type Device
Name Clear-K Low Vision Aid Treatment
Description 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.


Sequence: 79602756
Name AMD, vision impairment, blindness
Downcase Name amd, vision impairment, blindness

Design Outcomes

Sequence: 176795903
Outcome Type primary
Measure Best spectacle-corrected distance visual acuity (BCDVA)
Time Frame 12 months post-treatment
Description BCDVA measured using ETDRS eye charts

Browse Conditions

Sequence: 192827230 Sequence: 192827231 Sequence: 192827232 Sequence: 192827233 Sequence: 192827234 Sequence: 192827235 Sequence: 192827236 Sequence: 192827237 Sequence: 192827238
Mesh Term Blindness Mesh Term Macular Degeneration Mesh Term Retinal Degeneration Mesh Term Retinal Diseases Mesh Term Eye Diseases Mesh Term Vision Disorders Mesh Term Sensation Disorders Mesh Term Neurologic Manifestations Mesh Term Nervous System Diseases
Downcase Mesh Term blindness Downcase Mesh Term macular degeneration Downcase Mesh Term retinal degeneration Downcase Mesh Term retinal diseases Downcase Mesh Term eye diseases Downcase Mesh Term vision disorders Downcase Mesh Term sensation disorders Downcase Mesh Term neurologic manifestations Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48163601
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Optimal Acuity Corporation

Overall Officials

Sequence: 29189812
Role Principal Investigator
Name Michael Berry, PhD
Affiliation Optimal Acuity Corporation

Central Contacts

Sequence: 11971599
Contact Type primary
Name Michael Berry, PhD
Phone 831-869-1384
Role Contact

Design Group Interventions

Sequence: 67926196
Design Group Id 55409718
Intervention Id 52317126


Sequence: 30667695
Sampling Method Non-Probability Sample
Gender All
Minimum Age 50 Years
Maximum Age 100 Years
Healthy Volunteers Accepts Healthy Volunteers
Population Patients with dry age-related macular degeneration an legal blindness in one or both eyes
Criteria 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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254292353
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 50
Maximum Age Num 100
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1


Sequence: 30414481
Observational Model Cohort
Time Perspective Retrospective

Responsible Parties

Sequence: 28781002
Responsible Party Type Sponsor