Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-Lasik Patients With Monofocal IOLs
Multivariate Regression Analysis of Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-LASIK Patients With Monofocal IOLs
1 other identifier
observational
44
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedStudy Start
First participant enrolled
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedDecember 17, 2020
December 1, 2020
4 months
October 17, 2019
December 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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 Arms (2)
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
Eligibility Criteria
Post-LASIK patients, male and female, aged 40 and older, who have undergone cataract surgery or clear lens exchange
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702, United States
Related Publications (1)
Bucci FA Jr. Patient Satisfaction, Visual Outcomes, and Regression Analysis in Post-LASIK Patients Implanted With Multifocal, EDOF, or Monofocal IOLs. Eye Contact Lens. 2023 Apr 1;49(4):160-167. doi: 10.1097/ICL.0000000000000979. Epub 2023 Feb 22.
PMID: 36811831DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 22, 2019
Study Start
October 25, 2019
Primary Completion
March 1, 2020
Study Completion
December 1, 2020
Last Updated
December 17, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share