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

NCT ID: NCT04177771

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2021-12-20

Brief Summary

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).

Conditions

Aphakia; Cataract; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Light adjustable lens (LAL) and Light Delivery Device (LDD)

Group Type: EXPERIMENTAL

Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population

Intervention Type: DEVICE

Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments

SofPort LI61AO IOL

Group Type: ACTIVE_COMPARATOR

SofPort LI61AO IOL

Intervention Type: DEVICE

Control treatment group will receive SofPort LI61AO IOL

Tecnis ZCB00 or ZTC150 IOL

Intervention Type: DEVICE

Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL

Interventions

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

Intervention Type: DEVICE

SofPort LI61AO IOL

Control treatment group will receive SofPort LI61AO IOL

Intervention Type: DEVICE

Tecnis ZCB00 or ZTC150 IOL

Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RxSight, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vold Vision

Fayetteville, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSP-033

Identifier Type: -

Identifier Source: org_study_id