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

Not Applicable

Completed

Interventions: Device: Control IOL
Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)

Brief 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 & 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.

Arm && Interventions

Group	Intervention	Description
Control IOL	Control IOL	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Light adjustable lens (LAL) and Light Delivery Device (LDD)	Light Adjustable lens (LAL) and Light Delivery Device (LDD)	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.

Primary Outcome Measures

Name	Time	Method
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
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control	Postop Month 6
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control	Postop Month 6

Secondary Outcome Measures

Name	Time	Method
Uncorrected Distance Visual Acuity (UCDVA)	Postop Month 6
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

Locations (6): Focal Point Vision
🇺🇸
San Antonio, Texas, United States
Cleveland Eye Clinic
🇺🇸
Brecksville, Ohio, United States
The Eye Institute of Utah
🇺🇸
Salt Lake City, Utah, United States
Vance Thompson Vision Clinic
🇺🇸
Sioux Falls, South Dakota, United States
Discover Vision Centers
🇺🇸
Leawood, Kansas, United States
Slade & Baker Vision
🇺🇸
Houston, Texas, United States