A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)

NCT ID: NCT04005586

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-03-01

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.

Conditions

Aphakia; Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Light Delivery Device (LDD)

Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.

Group Type: EXPERIMENTAL

Light Delivery Device (LDD)

Intervention Type: DEVICE

Study eye will undergo Light delivery Device treatments

Interventions

Light Delivery Device (LDD)

Study eye will undergo Light delivery Device treatments

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments
• A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment.
• Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder.
• Between the ages of 40 and 80 inclusive on the day the informed consent form is signed.
• Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better.
• Willing and able to comply with the requirements for study specific procedures and visits

Exclusion Criteria

• Pre-existing macular disease in the study eye.
• History of uveitis in the study eye.
• Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and eyes with previous pterygium excision are permitted as long as 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.
• History of ocular herpes simplex virus in the study eye.
• Subject who has participated within another ophthalmic clinical trial within the last 3 months.
• Sutures used at the time of surgery to close the incision wound in the study eye

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RxSight, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Eye Clinic

Brecksville, Ohio, United States

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSP-034

Identifier Type: -

Identifier Source: org_study_id