A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.

Official Title
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A Prospective Controlled Multi-Center Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)

Conditions
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Aphakia, Cataract

Intervention / Treatment
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* Device: Light Delivery Device (LDD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment. Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder. Between the ages of 40 and 80 inclusive on the day the informed consent form is signed. Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better. Willing and able to comply with the requirements for study specific procedures and visits Exclusion Criteria: Pre-existing macular disease in the study eye. History of uveitis in the study eye. Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and 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 the study eye. Subject who has participated within another ophthalmic clinical trial within the last 3 months. Sutures used at the time of surgery to close the incision wound in the study 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
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive the same treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light Delivery Device (LDD)<br>Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. | Device: Light Delivery Device (LDD)<br>* Study eye will undergo Light delivery Device treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups |  | Post Op Month 3 | 
| Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups |  | Post Op Month 3 | 

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