RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

Last updated: September 16, 2024
Sponsor: RxSight, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

Control IOL

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

Clinical Study ID

NCT05202808
CSP-029
  • Ages 40-80
  • All Genders

Study Summary

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must sign a written Informed Consent form and be willing to undergo cataract surgeryfor the implantation of an IOL with random assignment to either the RxSight LAL orthe monofocal control IOL.

  • Between the ages of 40 and 80 inclusive on the day the cataract surgery isperformed.

  • Willing and able to comply with the requirements for study specific procedures andvisits.

  • Able to complete a written questionnaire in English.

Exclusion

Exclusion Criteria:

  • Pre-existing macular disease in either eye.

  • Patients with sufficiently dense cataracts that preclude examination of the maculain either eye.

  • History of uveitis in either eye.

  • Evidence of ectasia in either eye.

  • Previous intraocular surgery in either eye. Eyes with previous pterygium excisionare permitted as long as the pterygium did not extend more than 2mm onto the corneafrom 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 astamoxifen.

  • History of ocular herpes simplex virus in either eye.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Control IOL
Phase:
Study Start date:
December 03, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Vold Vision

    Fayetteville, Arkansas 72704
    United States

    Site Not Available

  • Reeve Woods Eye Center

    Chico, California 95926
    United States

    Site Not Available

  • The Eye Institute of West Florida

    Largo, Florida 33770
    United States

    Site Not Available

  • Newsom Eye

    Sebring, Florida 33870
    United States

    Site Not Available

  • Discover Vision Centers

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Vance Thompson Vision

    Alexandria, Minnesota 56308
    United States

    Site Not Available

  • Vance Thompson Vision

    Omaha, Nebraska 68137
    United States

    Site Not Available

  • Center for Sight

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Cleveland Eye Clinic

    Brecksville, Ohio 44141
    United States

    Site Not Available

  • Carolina Eyecare Physicians, LLC

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Vance Thompson Vision Clinic

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Key-Whitman Eye Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • Slade & Baker Vision

    Houston, Texas 77027
    United States

    Site Not Available

  • Slade & Baker Vision

    Houston, Texas 77027
    United States

    Site Not Available

  • Texas Eye Research Center

    Hurst, Texas 76054
    United States

    Site Not Available

  • Focal Point Vision

    San Antonio, Texas 78229
    United States

    Site Not Available

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