Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes

NCT ID: NCT04529616

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2022-10-01

Brief Summary

The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.

Conditions

Aphakia; Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Eligible eyes will receive Light adjustable lens with Light delivery Device treatments

Interventions

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

Eligible eyes will receive Light adjustable lens with Light delivery Device treatments

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
• Age 30 or older on the day the cataract surgery is performed.
• Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
• Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria

• Study eye with zonular laxity or dehiscence.
• Study eye with diabetes with any evidence of retinopathy.
• Study eye with history of uveitis.
• 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.
• Study eye with history of ocular herpes simplex virus.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RxSight, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CODET Vision Institute

Tijuana, , Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSP-036

Identifier Type: -

Identifier Source: org_study_id