Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

Study Overview
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Brief Summary
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The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.

Official Title
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A Single Center Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

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 preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D. 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 zonular laxity or dehiscence. Study eye with pseudoexfoliation. Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen. 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
Interventional Model Description: All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.
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>* Primary and Fellow 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 UCDVA of 20/20 or Better |  | 6 months | 

 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