CSP-025-01 Version 01
Research type
Research Study
Full title
A Prospective Randomized 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
IRAS ID
239937
Contact name
Sathish Srinivasan
Contact email
Sponsor organisation
RxSight, Inc.
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
For patients undergoing cataract surgery, the purpose of this study is to evaluate whether implantation of the RxSight Light Adjustable Lens (RxLAL) followed by and UV treatment can improve a patient's far vision without glasses while maintaining good quality of vision.
At birth, the natural lens in the eye is clear. Due to the aging process, the natural lens may gradually become "cloudy" which is a condition called a cataract. Individuals who develop a bothersome cataract generally choose to have surgery for removal of the cataract and implantation of an artificial intraocular lens (IOL) implant. The IOL is calculated to provide clear distance vision after surgery. However, a number of factors including not perfectly accurate preoperative measurements or surgical uncertainties may result in a residual prescription after surgery. Normally, if a residual prescription was present, glasses and/or further surgery would be required to improve distance vision postoperatively. With the RXLAL, the IOL power can be further adjusted after surgery.
Approximately 100 patients, ages 40-80, who have a cataract with a loss of vision, from up to 4 centers within Ireland, the United Kingdom, and Germany will participate in this study. The manufacturer of the RxLAL, RxSight, Inc. will fund this research.
17-24 days following surgery to implant the RxLAL, the study doctor will shine a beam of UV light onto the RXLAL in the patient’s eyes to adjust its power to correct for a residual prescription. Up to 3 adjustment treatments can be performed all separated by 3 to 7 days. After the final adjustment, the patient will receive up to two lock-in treatments using the LDD to stabilize the lens power and prevent any further changes in the patient’s vision. Following completion of all light treatments, the patient’s vision will be assessed 6 months postoperatively.
REC name
West of Scotland REC 3
REC reference
18/WS/0029
Date of REC Opinion
2 Mar 2018
REC opinion
Unfavourable Opinion