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

Completed

• Conditions: Patient Satisfaction

• Registration Number: NCT04134507
• Lead Sponsor: Bucci Laser Vision Institute

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-22
• Study Start: 2019-10-25
• Primary Completion: 2020-03-01
• Status Verified: 2020-12
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Bucci Laser Vision; 🇺🇸 Wilkes-Barre, Pennsylvania, United States