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OpenTrials
Completed

NCT Number: NCT04005586

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)

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Eye Clinic, Brecksville, Ohio, 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

  • 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

Treatment and study plan

Light Delivery Device (LDD)

Device

Study eye will undergo Light delivery Device treatments

Primary outcomes

  1. Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups

    Time frame: Post Op Month 3

  2. 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

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

RxSight, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2019
Registry last updated
Jun 11, 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.

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