ClinicalTrials.gg
WithdrawnNCT06488066Updated Jul 5, 2024

Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)

An observational study in Cataract and Pseudophakia, sponsored by Vance Thompson Vision. Withdrawn at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Vance Thompson Vision · Observational

Why this study was withdrawn
Never completed this study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).

02

Conditions studied

  • Cataract
  • Pseudophakia
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

Browse Cataract studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Up to 50 commercial patients who have been implanted with the LAL and who have completed Light Delivery Device (LDD) light treatments.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sign a written Document
  • Implanted commercially with the LAL and completed LDD light treatments

Exclusion criteria

Exclusion Criteria:

  • Previous corneal or intraocular surgery other than removal of cataract and implantation of the LAL
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • OtherData collection

    Collection of clinical data from groups of patients already implanted with the light adjustable lens (LAL) and have completed light treatments.

06

What researchers measure

Primary outcomes

  1. Manifest refraction

    A qualified ophthalmologist, optometrist, or a trained ophthalmic technician should obtain the refraction, in 0.25D steps, in a calibrated refraction lane. If the subject has a current pair of glasses for distance vision, they can be measured with a lensometer, and these measurements are used as the beginning approximate refraction

    Time frame: Pre operatively and immediately post operatively

07

Study locations

1 site
  • Vance Thompson Vision
    Sioux Falls, South Dakota 57108, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2021 (actual). Primary completion is estimated for Jan 2022, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2024
First posted
Jul 5, 2024
StartActual
Aug 13, 2021
Primary completionEst.
Jan 1, 2022
CompletionEst.
Jan 1, 2022
Last update
Jul 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06488066
Lead sponsor
Vance Thompson Vision
Responsible party
Sponsor
First posted
Jul 5, 2024
Start date
Aug 13, 2021
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Jul 5, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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