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

Not Applicable

Completed

• Conditions: Aphakia; Cataract
• Interventions: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)

• Registration Number: NCT03729024
• Lead Sponsor: RxSight, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-26
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Primary Completion: 2019-04-15
• Study Completion: 2020-02-04
• Results First Submitted: 2021-03-29
• Results First Submitted QC: 2021-04-28
• Results First Posted: 2021-05-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Light adjustable lens (LAL) and Light Delivery Device (LDD)	Light Adjustable lens (LAL) and Light Delivery Device (LDD)	-

Primary Outcome Measures

Name	Time	Method
Percent of Eyes With UCDVA of 20/20 or Better	6 months

Trial Locations

Locations (1)

CODET Vision Institute; 🇲🇽 Tijuana, Mexico