RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

Cataract Clinical Trial

Official title:

RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202808
• Other study ID #: CSP-029
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: RxSight, Inc.
• Contact: David B Goffredo
• Phone: 9494215463
• Email: dgoffredo[@]rxsight.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• 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 implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
• Willing and able to comply with the requirements for study specific procedures and visits.
• Able to complete a written questionnaire in English.

Exclusion Criteria:

• 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)
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
• Control IOL
Control treatment group will receive a Control IOL

Locations

Country	Name	City	State
United States	Vance Thompson Vision	Alexandria	Minnesota
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Reeve Woods Eye Center	Chico	California
United States	Key-Whitman Eye Center	Dallas	Texas
United States	Vold Vision	Fayetteville	Arkansas
United States	Slade & Baker Vision	Houston	Texas
United States	Texas Eye Research Center	Hurst	Texas
United States	The Eye Institute of West Florida	Largo	Florida
United States	Center for Sight	Las Vegas	Nevada
United States	Discover Vision Centers	Leawood	Kansas
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina
United States	Vance Thompson Vision	Omaha	Nebraska
United States	Focal Point Vision	San Antonio	Texas
United States	Newsom Eye	Sebring	Florida
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	Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control		Postop Month 6
Primary	Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control		Postop Month 6
Secondary	Rate of endothelial cell density loss		Postop Month 6
Secondary	Rate of retinal findings		Postop Month 6