A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

A Prospective Randomized Controlled Multi-center Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).

Study Overview

• Status: Terminated
• Conditions: Cataract; Presbyopia; Aphakia
• Intervention / Treatment: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population; Device: SofPort LI61AO IOL; Device: Tecnis ZCB00 or ZTC150 IOL

• Study Type: Interventional
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of either the LAL or SofPort LI61AO intraocular lens (IOL) (Bausch + Lomb).
• Must be willing to be randomized to either the LAL group (bilaterally implanted with the LAL and receive light treatments for refractive and presbyopia correction) or the Control group
• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
• Cataractous lens changes as demonstrated by best corrected distance visual acuity (BCDVA) 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:

• Pre-existing macular disease in either eye.
• Patient with sufficiently dense cataract that precludes examination of the macula in either eye.
• Diabetes with any evidence of retinopathy in either eye.
• Evidence of glaucomatous optic neuropathy in either eye.
• History of uveitis in either eye.
• Keratoconus or suspected of having keratoconus in either eye.
• Has undergone previous corneal or intraocular surgery in either eye, except 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 such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
• Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
• History of ocular herpes simplex virus in either eye.
• Subject who has participated within another ophthalmic clinical trial within the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population; Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Active Comparator: SofPort LI61AO IOL	Device: SofPort LI61AO IOL; Control treatment group will receive SofPort LI61AO IOL; Device: Tecnis ZCB00 or ZTC150 IOL; Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group	Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group.	Postop Month 6
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group	Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups	Postop Month 6
Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6	Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR	6 months
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group	Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups	Postop Month 6

Collaborators and Investigators

• Sponsor: RxSight, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Intraocular lens; Light Adjustable Lens; LAL
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Cataract; Presbyopia; Aphakia
• Other Study ID Numbers: CSP-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No