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

February 6, 2025 updated by: RxSight, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Tijuana, Mexico
        • CODET Vision Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Time Frame: 3 months post op
Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
3 months post op
Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better
Time Frame: 12 months post op
Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment
12 months post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RxSight, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2020

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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