Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism

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

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 Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: RxSight RxLAL

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany
    • University Eye Clinic
  • Heidelberg, Germany
    • University Eye Clinic
• United Kingdom
  • Scotland
    • Ayr, Scotland, United Kingdom
      • Ayrshire Eye Clinic and Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (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 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

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
Other: RxSight RxLAL IOL; Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)	Device: RxSight RxLAL; The patients will be assessed for 6 months; Other Names: Light Adjustable Lens; Light Delivery Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better	Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better	at 6 months postop

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated)	Number of study eyes experiencing Ocular adverse events (device related and unrelated)	Through study completion, an average of 6 months
Number of Eyes That Received Secondary Surgical Interventions (SSIs)	Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: RxSight, Inc.
• Investigators: Principal Investigator: Burkhard Dick, MD, University Eye Clinic- Bochum, Germany; Principal Investigator: Fritz Hengerer, MD, University Eye Clinic- Heidelberg, Germany; Principal Investigator: Sathish Srinivasan, MD, Ayrshire Eye Clinic and Laser Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: cataract surgery; eye disease; lenticular opacification
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: CSP-025-03

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