Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes

NCT04529616 | Completed Results

• 1 other identifier: CSP-036
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.

Conditions

Aphakia; Cataract

Keywords

Light Adjustable Lens; Intraocular lens; LAL

Outcome Measures

Primary Outcomes (2)

• Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better

  Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

  3 months post op

• Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better

  Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment

  12 months post op

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

Eligible eyes will receive Light adjustable lens with Light delivery Device treatments

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

Eligibility Criteria

• Age: 30 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.
• Age 30 or older on the day the cataract surgery is performed.
• 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 diabetes with any evidence of retinopathy.
• Study eye with history of uveitis.
• Subjects taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
• Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
• Study eye with history of ocular herpes simplex virus.

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: Associate Director, Clinical Trials
• Organization: RxSight, Inc.

dgoffredo@rxsight.com

9494215463

Publication Agreements

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

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: May 22, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)