An observational study in Dry Age-related Macular Degeneration and Vision Impairment and Blindness, sponsored by Optimal Acuity Corporation. Not yet recruiting. Open to participants aged 50 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Optimal Acuity Corporation · Observational
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.
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.
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's planned enrollment of 40 is below the median of 76 across 35 observational studies indexed under Blindness.
Browse Blindness studies →Optimal Acuity Corporation is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Compared within Blindness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vision Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with dry age-related macular degeneration an legal blindness in one or both eyes
IInclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Legally Blind Dry AMD Patients with either unilateral or bilateral blindness
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.
Best spectacle-corrected distance visual acuity (BCDVA)
BCDVA measured using ETDRS eye charts
Time frame: 12 months post-treatment
No study locations are listed for this record.
Plan to share: Undecided — Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Optimal Acuity Corporation