Clinical trial NCT05202808: RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study
Official title: RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Cataract
Keywords: Light Adjustable Lens
LAL
Intraocular lens
Lead sponsor: RxSight, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-24
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 2:1 to undergo experimental or control treatment.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
timeFrame: Postop Month 6
measure: Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
timeFrame: Postop Month 6
Secondary outcomes:
measure: Rate of Endothelial Cell Density Loss
timeFrame: Postop Month 6
measure: Rate of Retinal Findings
timeFrame: Postop Month 6
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Chico
country: United States
facility: Reeve Woods Eye Center
state: California
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: Sebring
country: United States
facility: Newsom Eye
state: Florida
city: Alexandria
country: United States
facility: Vance Thompson Vision
state: Minnesota
city: Omaha
country: United States
facility: Vance Thompson Vision
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Sight
state: Nevada
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision Clinic
state: South Dakota
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Houston
country: United States
facility: Slade &amp; Baker Vision
state: Texas
city: Hurst
country: United States
facility: Texas Eye Research Center
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
Study officials:
References: