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Completed

NCT Number: NCT05202808

RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

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.

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vold Vision, Fayetteville, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
  • Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
  • Willing and able to comply with the requirements for study specific procedures and visits.
  • Able to complete a written questionnaire in English.

Exclusion criteria

  • 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.

Treatment and study plan

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

Device

Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments

Control IOL

Device

Control treatment group will receive a Control IOL

Primary outcomes

  1. Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control

    Time frame: Postop Month 6

  2. Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control

    Time frame: Postop Month 6

Secondary outcomes

  1. Rate of Endothelial Cell Density Loss

    Time frame: Postop Month 6

    The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.

  2. Rate of Retinal Findings

    Time frame: Postop Month 6

    Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.

Sponsors and collaborators

Lead sponsor

RxSight, Inc.

Industry

Registry information

Official study title

RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2022
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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