Skip to main content
OpenTrials
Completed

NCT Number: NCT03771352

Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism

For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Clinic, Bochum, Germany

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 bilateral implantation of the RxLAL.
  • Greater than the age of 40 on the day the cataract surgery is performed.
  • Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.
  • Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
  • Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion criteria

  • Zonular laxity or dehiscence.
  • Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
  • Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
  • History of uveitis
  • Keratoconus or suspected of having keratoconus.
  • Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
  • Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.
  • Subjects taking systemic medications 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
  • History of congenital color vision defect

Treatment and study plan

RxSight RxLAL

Device

The patients will be assessed for 6 months

Other names: Light Adjustable Lens, Light Delivery Device

Primary outcomes

  1. Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better

    Time frame: at 6 months postop

    Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better

Other outcomes

  1. Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)

    Time frame: Through study completion, an average of 6 months

    Number of study eyes experiencing Ocular adverse events (device related and unrelated)

  2. Number of Eyes That Received Secondary Surgical Interventions (SSIs)

    Time frame: Through study completion, an average of 6 months

    Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.

Sponsors and collaborators

Lead sponsor

RxSight, Inc.

Industry

Registry information

Official study title

A Prospective Multi-Center Clinical Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RxLAL) With the Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 11, 2018
Registry last updated
Jun 9, 2021

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.

Published trials that share one or more normalized conditions with this study.