Vision Improvement for Patients With Age-Related Macular Degeneration (AMD)
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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
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 16, 2018 | ||||||||
First Posted Date ICMJE | February 13, 2020 | ||||||||
Last Update Posted Date | February 24, 2021 | ||||||||
Estimated Study Start Date ICMJE | June 1, 2021 | ||||||||
Estimated Primary Completion Date | September 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Vision Improvement for Patients With Age-Related Macular Degeneration | ||||||||
Official Title ICMJE | Vision Improvement for Patients With Age-Related Macular Degeneration | ||||||||
Brief Summary | 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. | ||||||||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Prospective, non-randomized, unmasked clinical study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Age-related Macular Degeneration | ||||||||
Intervention ICMJE | 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.
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Study Arms ICMJE | Experimental: Treatment arm
Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System.
Intervention: Device: Optimal Acuity Clear-K® Low Vision Aid System treatment
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
200 | ||||||||
Original Estimated Enrollment ICMJE |
120 | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||
Estimated Primary Completion Date | September 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 100 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04268836 | ||||||||
Other Study ID Numbers ICMJE | OAC #001 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Optimal Acuity Corporation | ||||||||
Study Sponsor ICMJE | Optimal Acuity Corporation | ||||||||
Collaborators ICMJE | Bochner Eye Institute | ||||||||
Investigators ICMJE |
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PRS Account | Optimal Acuity Corporation | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |