A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)

May 14, 2021 updated by: RxSight, Inc.

A Prospective Controlled Multi-Center Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)

The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • United States
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision Clinic

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments
  • A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment.
  • Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder.
  • Between the ages of 40 and 80 inclusive on the day the informed consent form is signed.
  • Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better.
  • Willing and able to comply with the requirements for study specific procedures and visits

Exclusion Criteria:

  • Pre-existing macular disease in the study eye.
  • History of uveitis in the study eye.
  • Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and 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 the study eye.
  • Subject who has participated within another ophthalmic clinical trial within the last 3 months.
  • Sutures used at the time of surgery to close the incision wound in the study eye

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 Delivery Device (LDD)
Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.
Device: Light Delivery Device (LDD)
Study eye will undergo Light delivery Device treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time Frame: Post Op Month 3
Post Op Month 3
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time Frame: Post Op Month 3
Post Op Month 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated)
Time Frame: Through study completion, an average of 3 months
Number of study eyes experiencing Ocular adverse events (device related and unrelated)
Through study completion, an average of 3 months

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)

July 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-034

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

Yes

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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