Clinical Outcomes of Patients with LAL+ in At Least One Eye

NCT ID: NCT06650358

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-16

Study Completion Date

2025-02-01

Brief Summary

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The objective of this study is to collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens+ (LAL+) in at least one eye

Detailed Description

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A retrospective-prospective, single-center study will be conducted. Patient charts will be retrospectively reviewed to collect data from the patient's comprehensive preoperative exam. Subjects will attend one stud visit post final LDD light treatment.

Conditions

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IOL, Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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LAL+

Bilateral pesudophakic adults implanted with the LAL+ in at least one eye

Light Adjustable Lens+

Intervention Type DEVICE

The Light Adjustable Lens+ (LAL+) is a posterior chamber, UV absorbing, three-piece, foldable, photo reactive silicone intraocular lens with a squared-posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure to the implanted LAL+ using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change postoperatively. A subsequent lock-in exposure is delivered to the implanted LAL+ to stabilize the lens power. The LAL+ has a modified aspheric anterior surface that creates a small continuous increase in central lens power, which is designed to slightly extend the depth of focus.

Interventions

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Light Adjustable Lens+

The Light Adjustable Lens+ (LAL+) is a posterior chamber, UV absorbing, three-piece, foldable, photo reactive silicone intraocular lens with a squared-posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure to the implanted LAL+ using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change postoperatively. A subsequent lock-in exposure is delivered to the implanted LAL+ to stabilize the lens power. The LAL+ has a modified aspheric anterior surface that creates a small continuous increase in central lens power, which is designed to slightly extend the depth of focus.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults with bilateral pseudophakia who have been implanted with the LAL+ in at least one eye and who have completed LDD light treatments
* Sign a written Informed Consent Form

Exclusion Criteria

* Visually significant eye disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frank A. Bucci, Jr., M.D.

OTHER

Sponsor Role lead

Responsible Party

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Frank A. Bucci, Jr., M.D.

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IIT-004-02

Identifier Type: -

Identifier Source: org_study_id

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