CataractNCT04196569
Trifocal Intraocular Lens (IOL) Aberrometry Outcomes
An observational study of Cataract, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Alcon Trifocal and Trifocal Toric Intraocular Lenses
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 13 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a diagnosis of visually-significant cataracts who meet the inclusion and exclusion criteria will be eligible for participation in this study.
Who may be able to join
- Able to consent to study and cataract surgery
- Visually significant cataract
- Potential post-operative visual acuity of 20/25 or better
- Age 18 years or older
Who cannot join
- Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss
- Irregular astigmatism
- Prior corneal refractive surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis
The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.
- Conditions
- Cataract
- Being tested
- Alcon Trifocal and Trifocal Toric Intraocular Lenses
- Keywords
- trifocal lens, trifocal intraocular lens, aberrometry
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon Trifocal and Trifocal Toric Intraocular LensesDevice
Panoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics:
TFAT30, TFAT40, TFAT50, TFAT60
| Study group | Role | What they receive |
|---|---|---|
| trifocal intraocular lens | Not described Receives: Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of spectacle independence (overall)
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Measured: 1 month post-cataract surgery
Percentage spectacle independence (overall)
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Measured: 3 months post-cataract surgery
Secondary outcomes (12)
Spectacle independence for distance, intermediate and near
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Measured: 1 month post-cataract surgery
Spectacle independence for distance, intermediate and near
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Measured: 3 months post-cataract surgery
Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Measured: 1 month post-cataract surgery
Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Measured: 3 months post-cataract surgery
Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target
This will be measured by visual acuity
Measured: 3 months post-cataract surgery
Subject satisfaction
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Measured: 3 months post-cataract surgery
Uncorrected binocular and monocular visual acuity at all distances
This will be measured by visual acuity
Measured: 3 months post-cataract surgery
Distribution of residual refractive error
This will be measured by refractive error
Measured: 3 months post-cataract surgery
Contrast sensitivity (binocular)
This will be measured by contrast sensitivity testing
Measured: 1 month post-cataract surgery
Contrast sensitivity (binocular)
This will be measured by contrast sensitivity testing
Measured: 3 months post-cataract surgery
Percentage of subjects with <=0.50 D of refractive cylinder
This will be measured by refractive error
Measured: 1 month post-cataract surgery
Percentage of subjects with <=0.50 D of refractive cylinder
This will be measured by refractive error
Measured: 3 months post-cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start12 Dec 2019
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
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.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Ashley Brissette, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196569
- Sponsor's protocol ID
- 19-05020251
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectacle Independence After Implantation of Trifocal and Trifocal Toric Intraocular Lenses Using Intraoperative Aberrometry: A Prospective Analysis
- ClinicalTrials.gov ID
- NCT04196569
- Acronym / sponsor ID
- 19-05020251
- Conditions
- Cataract
- Keywords
- trifocal lens, trifocal intraocular lens, aberrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 12 Dec 2019 (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 goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trifocal intraocular lens | – | Device: Alcon Trifocal and Trifocal Toric Intraocular Lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a diagnosis of visually-significant cataracts who meet the inclusion and exclusion criteria will be eligible for participation in this study.
Key inclusion criteria (4 listed)
- Able to consent to study and cataract surgery
- Visually significant cataract
- Potential post-operative visual acuity of 20/25 or better
- Age 18 years or older
Key exclusion criteria (3 listed)
- Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss
- Irregular astigmatism
- Prior corneal refractive surgery
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 |
|---|---|---|
| Alcon Trifocal and Trifocal Toric Intraocular LensesPanoptix Model #TFAT00 for the UV Absorbing Trifocal IOL. Torics: TFAT30, TFAT40, TFAT50, TFAT60 | Device | trifocal intraocular lens |
Primary outcome
Percentage of spectacle independence (overall)
Time frame: 1 month post-cataract surgery
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
Percentage spectacle independence (overall)
Time frame: 3 months post-cataract surgery
This will be assessed by a Visual Quality Questionnaire, an 18 question multiple choice questionnaire to assess vision-related functioning. Grading scale: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Mean value(s) will be analyzed.
12 secondary outcomes
Spectacle independence for distance, intermediate and near
Time frame: 1 month post-cataract surgery
Spectacle independence for distance, intermediate and near
Time frame: 3 months post-cataract surgery
Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)
Time frame: 1 month post-cataract surgery
Spectacle independence subgroup analysis for subjects within 0.50 D spherical equivalent (SE)
Time frame: 3 months post-cataract surgery
Binocular, uncorrected distance visual acuity for patients within 0.50 D of intended target
Time frame: 3 months post-cataract surgery
Subject satisfaction
Time frame: 3 months post-cataract surgery
Uncorrected binocular and monocular visual acuity at all distances
Time frame: 3 months post-cataract surgery
Distribution of residual refractive error
Time frame: 3 months post-cataract surgery
Contrast sensitivity (binocular)
Time frame: 1 month post-cataract surgery
Contrast sensitivity (binocular)
Time frame: 3 months post-cataract surgery
Percentage of subjects with <=0.50 D of refractive cylinder
Time frame: 1 month post-cataract surgery
Percentage of subjects with <=0.50 D of refractive cylinder
Time frame: 3 months post-cataract surgery
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 15 Dec 2022.
- 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.
Ashley Brissette, MD principal investigator
Weill Medical College of Cornell University
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, run by Weill Medical College of Cornell University 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 4 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 15 Dec 2022. 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?
Percentage of spectacle independence (overall) (time frame: 1 month post-cataract surgery). 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 15 Dec 2022.