Patient SatisfactionNCT04134507
Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-Lasik Patients With Monofocal IOLs
An observational study of Patient Satisfaction, run by Bucci Laser Vision Institute at 1 site in United States.
Trial summary
Compare functional visual outcomes and patient satisfaction of post-LASIK patients having received presbyopia-correcting IOLs versus post-LASIK patients having received monofocal IOLs Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2019to 1 Dec 2020
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Post-LASIK patients, male and female, aged 40 and older, who have undergone cataract surgery or clear lens exchange
Who may be able to join
- Post-LASIK
- Post cataract surgery
- Implantation of ZLB00, ZXR or ZXT, ZCB00, or AO60 intraocular lenses
- Spherical values greater than ± 0.50 and/or cylinder magnitude greater than 0.75D
Who cannot join
- Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
- Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
- Max sphere no greater than ± 0.50D and cylinder less than and/or equal to 0.75D
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: Multivariate Regression Analysis of Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-LASIK Patients With Monofocal IOLs
Compare functional visual outcomes and patient satisfaction of post-LASIK patients having received presbyopia-correcting IOLs versus post-LASIK patients having received monofocal IOLs
- Conditions
- Patient Satisfaction
- Keywords
- Post-LASIK, Presbyopia-correcting IOL, Monofocal IOL
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extended Depth of Focus IOL | Post-LASIK patients with implantation of a presbyopia-correcting IOL | |
| Monofocal IOL | Post-LASIK patients with implantation of a monofocal IOL |
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 and need for glasses for various visual functions at distance, intermediate, and near and overall satisfaction of visual function without glasses
Measured: Measured 3 months to 4 years after cataract surgery
Secondary outcomes (3)
Visual Acuity at Distance
Uncorrected and best corrected visual acuities measured at distance
Measured: Measured 3 months to 4 years after cataract surgery
Visual Acuity at Intermediate
Uncorrected and best corrected visual acuities measured at intermediate
Measured: Measured 3 months to 4 years after cataract surgery
Visual Acuity at Near
Uncorrected and best corrected visual acuities measured at near
Measured: Measured 3 months to 4 years; 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 posted22 Oct 2019
- Study start25 Oct 2019
- Primary completion1 Mar 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies 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
- Other
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucci Laser Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134507
- Sponsor's protocol ID
- FAB-USA-001
- Status last verified
- Dec 2020
- First submitted
- 17 Oct 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bucci FA Jr. Patient Satisfaction, Visual Outcomes, and Regression Analysis in Post-LASIK Patients Implanted With Multifocal, EDOF, or Monofocal IOLs. Eye Contact Lens. 2023 Apr 1;49(4):160-167. doi: 10.1097/ICL.0000000000000979. Epub 2023 Feb 22.
PubMed 36811831
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariate Regression Analysis of Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-LASIK Patients With Monofocal IOLs
- ClinicalTrials.gov ID
- NCT04134507
- Acronym / sponsor ID
- FAB-USA-001
- Conditions
- Patient Satisfaction
- Keywords
- Post-LASIK, Presbyopia-correcting IOL, Monofocal IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bucci Laser Vision InstituteUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Oct 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.
Compare functional visual outcomes and patient satisfaction of post-LASIK patients having received presbyopia-correcting IOLs versus post-LASIK patients having received monofocal IOLs
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Depth of Focus IOL | – | –Post-LASIK patients with implantation of a presbyopia-correcting IOL |
| Monofocal IOL | – | –Post-LASIK patients with implantation of a monofocal IOL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post-LASIK patients, male and female, aged 40 and older, who have undergone cataract surgery or clear lens exchange
Key inclusion criteria (4 listed)
- Post-LASIK
- Post cataract surgery
- Implantation of ZLB00, ZXR or ZXT, ZCB00, or AO60 intraocular lenses
- Spherical values greater than ± 0.50 and/or cylinder magnitude greater than 0.75D
Key exclusion criteria (3 listed)
- Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
- Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
- Max sphere no greater than ± 0.50D and cylinder less than and/or equal to 0.75D
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Satisfaction: subjective questionnaire
Time frame: Measured 3 months to 4 years after cataract surgery
Subjective questionnaire explores the frequency and need for glasses for various visual functions at distance, intermediate, and near and overall satisfaction of visual function without glasses
3 secondary outcomes
Visual Acuity at Distance
Time frame: Measured 3 months to 4 years after cataract surgery
Visual Acuity at Intermediate
Time frame: Measured 3 months to 4 years after cataract surgery
Visual Acuity at Near
Time frame: Measured 3 months to 4 years; after 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 17 Dec 2020.
- Derived from this study: PubMed 36811831Bucci FA Jr. Patient Satisfaction, Visual Outcomes, and Regression Analysis in Post-LASIK Patients Implanted With Multifocal, EDOF, or Monofocal IOLs. Eye Contact Lens. 2023 Apr 1;49(4):160-167. doi: 10.1097/ICL.0000000000000979. Epub 2023 Feb 22.
- 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 Patient Satisfaction, 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 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 17 Dec 2020. 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: Measured 3 months to 4 years after cataract surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04134507, which also lists 1 linked publication.
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 17 Dec 2020.