Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism

Study Overview
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Brief Summary
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For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.

Official Title
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A Prospective Multi-Center Clinical 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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Cataract

Intervention / Treatment
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* Device: RxSight RxLAL


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 bilateral implantation of the RxLAL. Greater than the age of 40 on the day the cataract surgery is performed. Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes. Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes. Willing and able to comply with the requirements for study specific procedures and visits. Exclusion Criteria: Zonular laxity or dehiscence. Age-related macular degeneration involving the presence of geographic atrophy or soft drusen. Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss. History of uveitis Keratoconus or suspected of having keratoconus. Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus. Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject. Subjects taking systemic medications 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 History of congenital color vision defect

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Other: RxSight RxLAL IOL<br>Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) | Device: RxSight RxLAL<br>* The patients will be assessed for 6 months<br>* Other names: Light Delivery Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better | at 6 months postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery, eye disease, lenticular opacification