CataractNCT04533191
Binocular Custom Vision Utilizing The 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-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Cataract, Pseudophakia
- What is being tested?
- LAL IOL lens
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Feb 2021
- 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 to 110 years
- All sexes
- Adult, Older adult
Study population: A population of 25 patients who plan to undergo bilateral cataract surgery with implantation of commercially available Light Adjustable Lens (LAL) and receive binocular custom vision.
Who may be able to join
- Patients able to sign informed consent
- Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.
Who cannot join
- Inability to sign informed consent
- Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
- Unable to return for light treatments
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-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.
- Conditions
- Cataract, Pseudophakia
- Being tested
- LAL IOL lens
- Medical subject headings
- Cataract, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAL IOL lensProcedure or surgery
Standard of care Cataract surgery with IOL placement
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with LAL lens | Subjects that underwent standard of care cataract surgery and LAL IOL placement. Receives: Procedure: LAL IOL lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular uncorrected distance, intermediate, and near visual acuity
Measured: Through Month one post-op
Binocular uncorrected depth of focus
Measured: Through Month one post-op
Secondary outcomes (5)
Manifest refraction
Measured: Through Month one post-op
Monocular uncorrected distance visual acuity
Measured: Through Month one post-op
Monocular best corrected distance visual acuity
Measured: Through Month one post-op
Visual Satisfaction
Visual satisfaction will be obtained using a visual questionnaire
Measured: Through Month one post-op
4th order total eye spherical aberration (Z12)
Measured: Through Month one post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Sep 2020
- Primary completion1 Jan 2021
- Study completion1 Feb 2021
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
- 25 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
- NCT04533191
- Sponsor's protocol ID
- IIT-001
- Status last verified
- May 2024
- First submitted
- 25 Aug 2020
- Last updated
- 20 May 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
- ClinicalTrials.gov ID
- NCT04533191
- Acronym / sponsor ID
- IIT-001
- Conditions
- Cataract, Pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 31 Aug 2020 (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-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with LAL lens | – | Procedure: LAL IOL lensSubjects that underwent standard of care cataract surgery and LAL IOL placement. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A population of 25 patients who plan to undergo bilateral cataract surgery with implantation of commercially available Light Adjustable Lens (LAL) and receive binocular custom vision.
Key inclusion criteria (2 listed)
- Patients able to sign informed consent
- Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.
Key exclusion criteria (3 listed)
- Inability to sign informed consent
- Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
- Unable to return for light treatments
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 |
|---|---|---|
| LAL IOL lensStandard of care Cataract surgery with IOL placement | Procedure or surgery | Subjects treated with LAL lens |
Primary outcome
Binocular uncorrected distance, intermediate, and near visual acuity
Time frame: Through Month one post-op
Binocular uncorrected depth of focus
Time frame: Through Month one post-op
5 secondary outcomes
Manifest refraction
Time frame: Through Month one post-op
Monocular uncorrected distance visual acuity
Time frame: Through Month one post-op
Monocular best corrected distance visual acuity
Time frame: Through Month one post-op
Visual Satisfaction
Time frame: Through Month one post-op
4th order total eye spherical aberration (Z12)
Time frame: Through Month one post-op
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 20 May 2024.
- Individual participant dataSharing planned: No
Related trials for Cataract
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
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 3 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 20 May 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?
Binocular uncorrected distance, intermediate, and near visual acuity (time frame: Through Month one post-op). 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 20 May 2024.