CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Light Adjustable lens (LAL) and Light Delivery Device (LDD) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03660865
NCT03660865N/ACompleted
CompareCT.gov

A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

RxSight, Inc.·interventional·Posted Sep 7, 2018·Updated Dec 23, 2021

In Brief

A clinical study evaluating Light Adjustable lens (LAL) and Light Delivery Device (LDD) and Control IOL for Aphakia and Cataract. Completed, enrolled 105 participants across 6 sites.

Detailed Summary

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAphakia, Cataract
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 7, 2018
Enrollment StartAug 28, 2018
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.8 years ago

Interventions

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

Primary eye will receive Light adjustable lens with Light delivery Device treatments

Control IOLdevice

Fellow eye will receive control IOL