- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04134507
Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-Lasik Patients With Monofocal IOLs
December 14, 2020 updated by: Bucci Laser Vision Institute
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Wilkes-Barre, Pennsylvania, United States, 18702
- Bucci Laser Vision
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Post-LASIK patients, male and female, aged 40 and older, who have undergone cataract surgery or clear lens exchange
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Measured 3 months to 4 years after cataract surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity at Distance
Time Frame: Measured 3 months to 4 years after cataract surgery
|
Uncorrected and best corrected visual acuities measured at distance
|
Measured 3 months to 4 years after cataract surgery
|
Visual Acuity at Intermediate
Time Frame: Measured 3 months to 4 years after cataract surgery
|
Uncorrected and best corrected visual acuities measured at intermediate
|
Measured 3 months to 4 years after cataract surgery
|
Visual Acuity at Near
Time Frame: Measured 3 months to 4 years; after cataract surgery
|
Uncorrected and best corrected visual acuities measured at near
|
Measured 3 months to 4 years; after cataract surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
October 17, 2019
First Submitted That Met QC Criteria
October 21, 2019
First Posted (Actual)
October 22, 2019
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 14, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAB-USA-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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