Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

Cataract Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660865
• Other study ID #: CSP-027
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2021
• Source: RxSight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of an intraocular lens (IOL).

• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.

• History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.

• Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes.

• Willing and able to comply with the requirements for study specific procedures and visits.

• Able to complete a written questionnaire in English.

Exclusion Criteria:

• Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.

• Pre-existing macular disease in either eye.

• Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.

• History of uveitis in either eye.

• Evidence of ectasia in either eye.

• Previous intraocular surgery in either eye. 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 either eye.

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Device:
• Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Primary eye will receive Light adjustable lens with Light delivery Device treatments
• Control IOL
Fellow eye will receive control IOL

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Slade & Baker Vision	Houston	Texas
United States	Discover Vision Centers	Leawood	Kansas
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Focal Point Vision	San Antonio	Texas
United States	Vance Thompson Vision Clinic	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
RxSight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control		Postop Month 6
Primary	Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control		Postop Month 6
Primary	One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%		Postop Month 6
Secondary	Uncorrected Distance Visual Acuity (UCDVA)		Postop Month 6
Secondary	Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination		Postop Month 6