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Clinical Trials/NCT04134507
NCT04134507
Completed
Not Applicable

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

Bucci Laser Vision Institute1 site in 1 country44 target enrollmentOctober 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Satisfaction
Sponsor
Bucci Laser Vision Institute
Enrollment
44
Locations
1
Primary Endpoint
Patient Satisfaction: subjective questionnaire
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 25, 2019
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bucci Laser Vision Institute
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Visual Acuity at Distance(Measured 3 months to 4 years after cataract surgery)
  • Visual Acuity at Intermediate(Measured 3 months to 4 years after cataract surgery)
  • Visual Acuity at Near(Measured 3 months to 4 years; after cataract surgery)

Study Sites (1)

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