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

NCT ID: NCT03729024

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-26
• Study Completion Date: 2020-02-04

Brief Summary

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.

Conditions

Aphakia; Cataract

Study Design

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

Study Groups

Light adjustable lens (LAL) and Light Delivery Device (LDD)

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

Interventions

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

Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

CODET Vision Institute

Tijuana, , Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CSP-028

Identifier Type: -

Identifier Source: org_study_id