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

RxSight, Inc.1 site in 1 country21 target enrollmentJanuary 26, 2018

ConditionsAphakia Cataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aphakia
Sponsor: RxSight, Inc.
Enrollment: 21
Locations: 1
Primary Endpoint: Percent of Eyes With UCDVA of 20/20 or Better
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 26, 2018

End Date

February 4, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

RxSight, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.