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

Sponsor

Bucci Laser Vision Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04134507

Collaborator

(none)

Enrollment

Location

13.2

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction

Study Design

Study Type:

Observational

Actual Enrollment :

44 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 25, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Patient Satisfaction: subjective questionnaire [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

Secondary Outcome Measures

Visual Acuity at Distance [Measured 3 months to 4 years after cataract surgery]
Uncorrected and best corrected visual acuities measured at distance
Visual Acuity at Intermediate [Measured 3 months to 4 years after cataract surgery]
Uncorrected and best corrected visual acuities measured at intermediate
Visual Acuity at Near [Measured 3 months to 4 years; after cataract surgery]
Uncorrected and best corrected visual acuities measured at near

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bucci Laser Vision	Wilkes-Barre	Pennsylvania	United States	18702

Sponsors and Collaborators

Bucci Laser Vision Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bucci Laser Vision Institute

ClinicalTrials.gov Identifier:

NCT04134507

Other Study ID Numbers:

FAB-USA-001

First Posted:

Oct 22, 2019

Last Update Posted:

Dec 17, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bucci Laser Vision Institute

Post-LASIK

Presbyopia-correcting IOL

Monofocal IOL

Additional relevant MeSH terms:

Presbyopia

Study Results

No Results Posted as of Dec 17, 2020