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Enrolling by invitation NCT06650358

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

Observational IOL, Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Light Adjustable Lens+.
Who it may be relevant to
Registry conditions: IOL, Cataract. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

CLINICAL OUTCOMES of BILATERAL PSEUDOPHAKIC PATIENTS with a LIGHT ADJUSTABLE LENS+ (LAL)+ IMPLANTED in AT LEAST ONE EYE

Overview

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

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.

Interventions

  • Device 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 subsequen

Primary outcome measures

  • Patient Satisfaction [Time frame: 3-18 months after phacoemulsification]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Bucci Laser Vision Institute — Wilkes-Barre

Identifiers

NCT: NCT06650358 · IIT-004-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗