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

NCT03729024 | Completed Results FDA Device

• 1 other identifier: CSP-028
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Light Adjustable Lens; Intraocular lens; LAL

Outcome Measures

Primary Outcomes (1)

• Percent of Eyes With UCDVA of 20/20 or Better

  6 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RxSight, Inc.: lead

Study Sites (1)

CODET Vision Institute

Tijuana, Mexico

Location

MeSH Terms

Conditions

Aphakia; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Jeffrey Ha, Senior Director of Clinical Research
• Organization: RxSight

jha@rxsight.com

949-521-7870

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: January 26, 2018
• Primary Completion: April 15, 2019
• Study Completion: February 4, 2020
• Last Updated: August 6, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)