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Enrolling by invitation NCT07347379

Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study

— Observational Aphakia 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 (LAL) and Light Delivery Device (LDD), Control IOL.
Who it may be relevant to
Registry conditions: Aphakia 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 →

Unsure about the terms? Read our patient guide →

Overview

This is an observational, follow up study of subjects previously enrolled in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study". The primary objective of this study is to collect long-term safety and effectiveness data on RxSight LAL and Control IOL in subjects previously implanted in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study".

Interventions

  • Device Light Adjustable lens (LAL) and Light Delivery Device (LDD)
    Experimental treatment group received Light adjustable lens with Light delivery Device treatments
  • Device Control IOL
    Control treatment group received a Control IOL

Primary outcome measures

  • Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit compared between the RxSight LAL and Control group [Time frame: Up to 55 months]
  • Mean manifest cylinder at the Long-Term follow up visit compared between the RxSight LAL and Control group [Time frame: Up to 55 months]

Eligibility criteria

Inclusion criteria

  • Subject and study eye with prior participation in the CSP-029 study.

Exclusion criteria

  • Subjects with serious co-morbid conditions that in the judgment of the investigator makes inclusion in the study not in the best interest of the subject.

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
  • Focal Point Vision — San Antonio

Identifiers

NCT: NCT07347379 · CSP-1003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗