IOLNCT06016231
Clinical Outcomes of Patients with a Light Adjustable Lens (LAL) in At Least One Eye
An observational study of IOL, run by Bucci Laser Vision Institute at 1 site in United States.
Trial summary
To collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens (LAL) in at least one eye Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IOL
- What is being tested?
- Light Adjustable Lens
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bilateral pseudophakia in adults implanted with the LAL in at least one eye and who have completed Light Delivery Device (LDD) light treatments
Who may be able to join
- Adults with bilateral pseudophakia who have been implanted with the LAL in at least one eye and who have completed LDD light treatments
Who cannot join
- Visually significant eye disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: Clinial Outcomes of Bilateral Pseudophakic Patients with a Light Adjustable Lens (LAL) Implanted in At Least One Eye
To collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens (LAL) in at least one eye
- Conditions
- IOL
- Being tested
- Light Adjustable Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Adjustable LensDevice
The Light Adjustable Lens (LAL) is a posterior chamber, UV absorbing, three-piece, foldable, photoreactive silicone intraocular lens with a squared posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure of the implanted RxSight LAL using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change post-operatively. A subsequent lock-in exposure is delivered to the implanted LAL to stabilize the lens power.
| Study group | Role | What they receive |
|---|---|---|
| LAL in at least one eye | Not described Receives: Device: Light Adjustable Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction - subjective questionnaire
Subjective questionnaire explores the frequency/need for glasses for various visual functions at distance/intermediate/near, experience with dysphotopsias, and overall satisfaction of visual function without glasses.
Measured: 3-18 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start15 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IOLStudies 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
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucci Laser Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank A Bucci, MD, Principal investigator, Bucci Laser Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016231
- Sponsor's protocol ID
- IIT-004
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinial Outcomes of Bilateral Pseudophakic Patients with a Light Adjustable Lens (LAL) Implanted in At Least One Eye
- ClinicalTrials.gov ID
- NCT06016231
- Acronym / sponsor ID
- IIT-004
- Conditions
- IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bucci Laser Vision InstituteUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Aug 2023 (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.
To collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens (LAL) in at least one eye
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAL in at least one eye | – | Device: Light Adjustable Lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bilateral pseudophakia in adults implanted with the LAL in at least one eye and who have completed Light Delivery Device (LDD) light treatments
Key inclusion criteria (1 listed)
- Adults with bilateral pseudophakia who have been implanted with the LAL in at least one eye and who have completed LDD light treatments
Key exclusion criteria (1 listed)
- Visually significant eye disease
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 LensThe Light Adjustable Lens (LAL) is a posterior chamber, UV absorbing, three-piece, foldable, photoreactive silicone intraocular lens with a squared posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure of the implanted RxSight LAL using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change post-operatively. A subsequent lock-in exposure is delivered to the implanted LAL to stabilize the lens power. | Device | LAL in at least one eye |
Primary outcome
Patient Satisfaction - subjective questionnaire
Time frame: 3-18 months after cataract surgery
Subjective questionnaire explores the frequency/need for glasses for various visual functions at distance/intermediate/near, experience with dysphotopsias, and overall satisfaction of visual function without glasses.
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 21 Oct 2024.
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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.
Frank A Bucci, MD principal investigator
Bucci Laser Vision Institute
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 IOL, run by Bucci Laser Vision Institute 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 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 21 Oct 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 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?
Patient Satisfaction - subjective questionnaire (time frame: 3-18 months after cataract surgery). 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 21 Oct 2024.