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NCT04134507 Clinical Trial

Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-Lasik Patients With Monofocal IOLs

Patient Satisfaction Clinical Trial

Official title:
Multivariate Regression Analysis of Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-LASIK Patients With Monofocal IOLs

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04134507
Other study ID # FAB-USA-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 25, 2019
Est. completion date December 1, 2020

Study information
Verified date December 2020
Source Bucci Laser Vision Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date December 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Bucci Laser Vision Wilkes-Barre Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Bucci Laser Vision Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 3 months to 4 years after cataract surgery
Secondary Visual Acuity at Distance Uncorrected and best corrected visual acuities measured at distance Measured 3 months to 4 years after cataract surgery
Secondary Visual Acuity at Intermediate Uncorrected and best corrected visual acuities measured at intermediate Measured 3 months to 4 years after cataract surgery
Secondary Visual Acuity at Near Uncorrected and best corrected visual acuities measured at near Measured 3 months to 4 years; after cataract surgery
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