RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

• Sponsor: RxSight, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05202808
• Collaborator: (none)
• Enrollment: 500
• Locations: 14
• Arms: 2
• Anticipated Duration (Months): 35.9
• Patients Per Site: 35.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aphakia; Cataract	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Device: Control IOL	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized 2:1 to undergo experimental or control treatment.Subjects will be randomized 2:1 to undergo experimental or control treatment.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
• Actual Study Start Date: Dec 3, 2021
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Active Comparator: Control IOL	Device: Control IOL; Control treatment group will receive a Control IOL

Outcome Measures

Primary Outcome Measures

1. Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control [Postop Month 6]

2. Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control [Postop Month 6]

Secondary Outcome Measures

1. Rate of endothelial cell density loss [Postop Month 6]

2. Rate of retinal findings [Postop Month 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vold Vision	Fayetteville	Arkansas	United States	72704
2	The Eye Institute of West Florida	Largo	Florida	United States	33770
3	Newsom Eye	Sebring	Florida	United States	33870
4	Discover Vision Centers	Leawood	Kansas	United States	66211
5	Vance Thompson Vision	Alexandria	Minnesota	United States	56308
6	Vance Thompson Vision	Omaha	Nebraska	United States	68137
7	Center for Sight	Las Vegas	Nevada	United States	89145
8	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141
9	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina	United States	29464
10	Vance Thompson Vision Clinic	Sioux Falls	South Dakota	United States	57108
11	Key-Whitman Eye Center	Dallas	Texas	United States	75235
12	Slade & Baker Vision	Houston	Texas	United States	77027
13	Texas Eye Research Center	Hurst	Texas	United States	76054
14	Focal Point Vision	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• RxSight, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RxSight, Inc.
• ClinicalTrials.gov Identifier: NCT05202808
• Other Study ID Numbers: CSP-029
• First Posted: Jan 24, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by RxSight, Inc.: Light Adjustable Lens; LAL; Intraocular lens
• Additional relevant MeSH terms: Cataract; Aphakia

Study Results

No Results Posted as of Jul 8, 2022