Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

November 22, 2021 updated by: RxSight, Inc.

A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

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
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Discover Vision Centers
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision Clinic
    • Texas
      • Houston, Texas, United States, 77027
        • Slade & Baker Vision
      • San Antonio, Texas, United States, 78229
        • Focal Point Vision
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah

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:

  • Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of an intraocular lens (IOL).
  • Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
  • History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.
  • Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level 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:

  • Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.
  • Pre-existing macular disease in either eye.
  • Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
  • History of uveitis in either eye.
  • Evidence of ectasia in either eye.
  • Previous intraocular surgery in either eye. 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 either 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: Randomized
  • 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)
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Primary eye will receive Light adjustable lens with Light delivery Device treatments
Active Comparator: Control IOL
A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Device: Control IOL
Fellow eye will receive control IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time Frame: Postop Month 6
Postop Month 6
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time Frame: Postop Month 6
Postop Month 6
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
Time Frame: Postop Month 6
Postop Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Uncorrected Distance Visual Acuity (UCDVA)
Time Frame: Postop Month 6
Postop Month 6
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Time Frame: Postop Month 6
Postop Month 6

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)

August 28, 2018

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-027

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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