An interventional study of Optimal Acuity Clear-K® Low Vision Aid System treatment in Age-related Macular Degeneration, sponsored by Optimal Acuity Corporation. Not yet recruiting at 1 site in Canada. 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 · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision for patients with age-related macular degeneration.
The Optimal Acuity Clear-K® Low Vision Aid System treats corneas with near infrared light in order to change the modulus of small volumes of anterior stromal corneal tissue. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision.
200 AMD patients meeting eligibility requirements will be treated. The study will record and analyze pre-treatment (Tx) and post-Tx examinations with follow-up extending to 24 months post-Tx. Analysis will include descriptive statistics and measures of correlation between outcomes and patient baseline characteristics.
The primary objective of the study is to evaluate the safety and effectiveness of Clear-K® treatment in providing vision improvement to AMD patients.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 200 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Optimal Acuity Corporation is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System.
Device: Optimal Acuity Clear-K® Low Vision Aid System treatment
The treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change.
Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx
CDVA will be measured using ETDRS letter scoring both pre-Tx and post-Tx with follow-up to 24 months post-Tx
Time frame: Through study completion, an average of 2 years
Visual Function Questionnaire (VFQ)-25 quality of life assessment
The VFQ-25 instrument will be used to assess patient quality of life measures.
Time frame: Through study completion, an average of 2 years
Plan to share: No
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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