CataractNCT06488066
Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)
An observational study of Cataract and Pseudophakia, run by Vance Thompson Vision at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract, Pseudophakia
- What is being tested?
- Data collection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 1 Jan 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 50 commercial patients who have been implanted with the LAL and who have completed Light Delivery Device (LDD) light treatments.
Who may be able to join
- Sign a written Informed Consent Document
- Implanted commercially with the LAL and completed LDD light treatments
Who cannot join
- Previous corneal or intraocular surgery other than removal of cataract and implantation of the LAL
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).
- Conditions
- Cataract, Pseudophakia
- Being tested
- Data collection
- Medical subject headings
- Cataract, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collection of clinical data from groups of patients already implanted with the light adjustable lens (LAL) and have completed light treatments.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre operatively and immediately post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start13 Aug 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Why it stopped: Never completed this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488066
- Sponsor's protocol ID
- IIT-002
- Status last verified
- Jul 2024
- First submitted
- 16 May 2024
- Last updated
- 5 Jul 2024
- Results posted
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)
- ClinicalTrials.gov ID
- NCT06488066
- Acronym / sponsor ID
- IIT-002
- Conditions
- Cataract, Pseudophakia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never completed this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 5 Jul 2024 (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.
The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 50 commercial patients who have been implanted with the LAL and who have completed Light Delivery Device (LDD) light treatments.
Key inclusion criteria (2 listed)
- Sign a written Informed Consent Document
- Implanted commercially with the LAL and completed LDD light treatments
Key exclusion criteria (1 listed)
- Previous corneal or intraocular surgery other than removal of cataract and implantation of the LAL
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 |
|---|---|---|
| Data collectionCollection of clinical data from groups of patients already implanted with the light adjustable lens (LAL) and have completed light treatments. | Other | – |
Primary outcome
Manifest refraction
Time frame: Pre operatively and immediately post operatively
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Pseudophakia, run by Vance Thompson Vision at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Manifest refraction (time frame: Pre operatively and immediately post operatively). 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 5 Jul 2024.