Aphakia CataractNCT07347379
Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
An observational study of Aphakia Cataract, run by RxSight, Inc. at 6 sites in United States.
Trial 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 in subjects previously implanted in the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphakia Cataract
- What is being tested?
- Light Adjustable lens (LAL) and Light Delivery Device (LDD)
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Nov 2025to 9 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include up to 335 subjects who were previously implanted with the LAL in the CSP-029 study.
Who may be able to join
- Subject and study eye with prior participation in the CSP-029 study and implanted with the LAL.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Vance Thompson Vision
Alexandria, Minnesota, 56308
Key-Whitman Eye Center
Dallas, Texas, 75235
Slade & Baker Vision
Houston, Texas, 77027
Texas Eye Research Center
Hurst, Texas, 76054
Vance Thompson Vision
Omaha, Nebraska, 68137
Focal Point Vision
San Antonio, Texas, 78229
About this study
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 in subjects previously implanted in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study".
- Conditions
- Aphakia Cataract
- Being tested
- Light Adjustable lens (LAL) and Light Delivery Device (LDD)
- Keywords
- Light Adjustable Lens LAL Intraocular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Adjustable lens (LAL) and Light Delivery Device (LDD)Device
Experimental treatment group received Light adjustable lens with Light delivery Device treatments
| Study group | Role | What they receive |
|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Light adjustable lens (LAL) and Light Delivery Device (LDD) Receives: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit
Measured: Up to 55 months
Mean manifest cylinder at the Long-Term follow up visit
Measured: Up to 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start13 Nov 2025
- Primary completion17 Aug 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphakia CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- RxSight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347379
- Sponsor's protocol ID
- CSP-1003
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
- ClinicalTrials.gov ID
- NCT07347379
- Acronym / sponsor ID
- CSP-1003
- Conditions
- Aphakia Cataract
- Keywords
- Light Adjustable Lens LAL Intraocular lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- RxSight, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in subjects previously implanted in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | – | Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)Light adjustable lens (LAL) and Light Delivery Device (LDD) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include up to 335 subjects who were previously implanted with the LAL in the CSP-029 study.
Key inclusion criteria (1 listed)
- Subject and study eye with prior participation in the CSP-029 study and implanted with the LAL.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light Adjustable lens (LAL) and Light Delivery Device (LDD)Experimental treatment group received Light adjustable lens with Light delivery Device treatments | Device | Light adjustable lens (LAL) and Light Delivery Device (LDD) |
Primary outcome
Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit
Time frame: Up to 55 months
Mean manifest cylinder at the Long-Term follow up visit
Time frame: Up to 55 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphakia Cataract, run by RxSight, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit (time frame: Up to 55 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.