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

RxSight, Inc.2 sites in 2 countries55 target enrollmentJune 19, 2018

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: RxSight, Inc.
Enrollment: 55
Locations: 2
Primary Endpoint: Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 19, 2018

End Date

July 1, 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 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