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Clinical Trials/NCT03771352
NCT03771352CompletedNot Applicable

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

RxSight, Inc.3 sites in 2 countries55 target enrollmentStarted: June 19, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Locations
3
Primary Endpoint
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

RxSight RxLAL IOL

Other

Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)

Intervention: RxSight RxLAL (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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