RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study
NCT ID: NCT05202808
Last Updated: 2025-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2021-12-03
2024-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Light adjustable lens (LAL) and Light Delivery Device (LDD)
Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Control IOL
Control IOL
Control treatment group will receive a Control IOL
Interventions
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Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Control IOL
Control treatment group will receive a Control IOL
Eligibility Criteria
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Inclusion Criteria
* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
* Willing and able to comply with the requirements for study specific procedures and visits.
* Able to complete a written questionnaire in English.
Exclusion Criteria
* Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
* History of uveitis in either eye.
* Evidence of ectasia in either eye.
* Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
* Subjects taking systemic medication that may increase sensitivity to UV light.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* History of ocular herpes simplex virus in either eye.
40 Years
80 Years
ALL
No
Sponsors
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RxSight, Inc.
INDUSTRY
Responsible Party
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Locations
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Vold Vision
Fayetteville, Arkansas, United States
Reeve Woods Eye Center
Chico, California, United States
The Eye Institute of West Florida
Largo, Florida, United States
Newsom Eye
Sebring, Florida, United States
Vance Thompson Vision
Alexandria, Minnesota, United States
Vance Thompson Vision
Omaha, Nebraska, United States
Center for Sight
Las Vegas, Nevada, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, United States
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Slade & Baker Vision
Houston, Texas, United States
Texas Eye Research Center
Hurst, Texas, United States
Focal Point Vision
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CSP-029
Identifier Type: -
Identifier Source: org_study_id
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