RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

Study Overview
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Brief Summary
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The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

Official Title
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RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study

Conditions
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Aphakia, Cataract

Intervention / Treatment
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* Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
* Device: Control IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL. 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: Pre-existing macular disease in either eye. 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized 2:1 to undergo experimental or control treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)<br> | Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)<br>* Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments<br>|
| Active Comparator: Control IOL<br> | Device: Control IOL<br>* Control treatment group will receive a Control IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control |  | Postop Month 6 | 
| Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control |  | Postop Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of endothelial cell density loss |  | Postop Month 6 | 
| Rate of retinal findings |  | Postop Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Light Adjustable Lens, LAL, Intraocular lens