NCT07347379

Brief Summary

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".

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Nov 2025Sep 2026

Study Start

First participant enrolled

November 13, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

December 4, 2025

Last Update Submit

January 8, 2026

Conditions

Aphakia Cataract

Keywords

Light Adjustable Lens LAL Intraocular lens

Outcome Measures

Primary Outcomes (2)

  • Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit compared between the RxSight LAL and Control group

    Up to 55 months

  • Mean manifest cylinder at the Long-Term follow up visit compared between the RxSight LAL and Control group

    Up to 55 months

Study Arms (2)

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

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

Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)

Control IOL

Control IOL

Device: Control IOL

Interventions

Light Adjustable lens (LAL) and Light Delivery Device (LDD)DEVICE

Experimental treatment group received Light adjustable lens with Light delivery Device treatments

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

Control treatment group received a Control IOL

Control IOL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include up to 500 subjects who previously participated in the CSP-029 study.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Focal Point Vision

San Antonio, Texas, 78229, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 16, 2026

Study Start

November 13, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)