Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes

Study Overview
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Brief Summary
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The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.

Official Title
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A Single Center Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes

Conditions
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Aphakia, Cataract

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


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 unilateral or bilateral implantation of the RxLAL. Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source. Willing and able to comply with the requirements for study specific procedures and visits. Exclusion Criteria: Study eye with pseudoexfoliation. Study eye with diabetes with any evidence of retinopathy. Study eye with evidence of glaucomatous optic neuropathy. Study eye with history of uveitis. Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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. Study eye with history of ocular herpes simplex virus. Study eye with history of a congenital color vision defect

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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>* Eligible eyes will receive Light adjustable lens with Light delivery Device treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better |  | 3 months post op | 

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