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OpenTrials
Completed

NCT Number: NCT03729024

Exploratory 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

The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CODET Vision Institute

Tijuana, Mexico

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 unilateral or bilateral implantation of the RxLAL.
  • Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
  • Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
  • Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
  • Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion criteria

  • Study eye with zonular laxity or dehiscence.
  • Study eye with pseudoexfoliation.
  • Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
  • Study eye with diabetes with any evidence of retinopathy.
  • Study eye with evidence of glaucomatous optic neuropathy.
  • Study eye with history of uveitis.
  • Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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.
  • Study eye with history of ocular herpes simplex virus.
  • Study eye with history of a congenital color vision defect

Treatment and study plan

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

Device

Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

Primary outcomes

  1. Percent of Eyes With UCDVA of 20/20 or Better

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

RxSight, Inc.

Industry

Registry information

Official study title

A Single Center Exploratory 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
Nov 2, 2018
Registry last updated
Aug 6, 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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