A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

NCT04177771 | Terminated Results

• 1 other identifier: CSP-033
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).

Conditions

Aphakia; Cataract; Presbyopia

Keywords

Light Adjustable Lens; Intraocular lens; LAL

Outcome Measures

Primary Outcomes (4)

• Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group

  Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group.

  Postop Month 6

• Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group

  Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups

  Postop Month 6

• Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6

  Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR

  6 months

• Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group

  Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups

  Postop Month 6

Study Arms (2)

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

EXPERIMENTAL

Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population

SofPort LI61AO IOL

ACTIVE COMPARATOR

Device: SofPort LI61AO IOL; Device: Tecnis ZCB00 or ZTC150 IOL

Interventions

Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population DEVICE

Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments

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

SofPort LI61AO IOL DEVICE

Control treatment group will receive SofPort LI61AO IOL

SofPort LI61AO IOL

Tecnis ZCB00 or ZTC150 IOL DEVICE

Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL

SofPort LI61AO IOL

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 the bilateral implantation of either the LAL or SofPort LI61AO intraocular lens (IOL) (Bausch + Lomb).
• Must be willing to be randomized to either the LAL group (bilaterally implanted with the LAL and receive light treatments for refractive and presbyopia correction) or the Control group
• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
• Cataractous lens changes as demonstrated by best corrected distance visual acuity (BCDVA) of 20/40 or worse with or without a glare source in both eyes.
• Willing and able to comply with the requirements for study specific procedures and visits.
• Able to complete a written questionnaire in English.

You may not qualify if:

• Pre-existing macular disease in either eye.
• Patient with sufficiently dense cataract that precludes examination of the macula in either eye.
• Diabetes with any evidence of retinopathy in either eye.
• Evidence of glaucomatous optic neuropathy in either eye.
• History of uveitis in either eye.
• Keratoconus or suspected of having keratoconus in either eye.
• Has undergone previous corneal or intraocular surgery in either eye, except 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 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.
• History of ocular herpes simplex virus in either eye.
• Subject who has participated within another ophthalmic clinical trial within the last 3 months.

Sponsors & Collaborators

• RxSight, Inc.: lead

Study Sites (1)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Aphakia; Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Limitations and Caveats

Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely. Per the protocol, these subjects will be excluded from the Full Analysis Set populations. Based on the sample size calculations, at least 42 subjects per lens group with available monocular photopic BCDVA and DCIVA for the primary eyes at Postop Month 6 were needed; however, the sample size was too small to analyze these endpoints.

Results Point of Contact

• Title: Jeffrey Ha, VP Clinical Affairs
• Organization: RxSight

jha@rxsight.com

949-521-7870

Publication Agreements

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

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Select post operative assessments will be performed on both the experimental and control treatment groups by an examiner who will be masked to the treatment group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 to undergo experimental or control treatment.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: November 15, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)