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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Aphakia
• Intervention / Treatment: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Tijuana, Mexico
    • Codet Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD)	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD); Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of Eyes With UCDVA of 20/20 or Better	6 months

Collaborators and Investigators

• Sponsor: RxSight, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): February 4, 2020

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Intraocular lens; Light Adjustable Lens; LAL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism; Aphakia
• Other Study ID Numbers: CSP-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes