Vision Improvement for Patients With Age-Related Macular Degeneration (AMD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04268836|
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Age-related Macular Degeneration||Device: Optimal Acuity Clear-K® Low Vision Aid System treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, non-randomized, unmasked clinical study|
|Masking:||None (Open Label)|
|Official Title:||Vision Improvement for Patients With Age-Related Macular Degeneration|
|Estimated Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Treatment arm
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 [ Time Frame: Through study completion, an average of 2 years ]CDVA will be measured using ETDRS letter scoring both pre-Tx and post-Tx with follow-up to 24 months post-Tx
- Visual Function Questionnaire (VFQ)-25 quality of life assessment [ Time Frame: Through study completion, an average of 2 years ]The VFQ-25 instrument will be used to assess patient quality of life measures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268836
|Contact: Michael Berry, PhDfirstname.lastname@example.org|
|Contact: Samuel Markowitz, MD, FRCSCemail@example.com|
|1929 Bayview Ave., Suite 117|
|Toronto, Ontario, Canada, M4G 3E8|
|Contact: Samuel Markowitz, MD, FRCSC 4165315425 firstname.lastname@example.org|
|Principal Investigator: Samuel N Markowitz, MD, FRCSC|
|Study Director:||Michael Berry, PhD||Optimal Acuity Corporation|