Study on the Accuracy of Intraocular Lens Calculation Formula
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05672693
Collaborator
(none)
500
1
23
21.7
Study Details
Study Description
Brief Summary
In this study, we will retrospectively collect patients who have performed phacoemulsification combined with intraocular lens implantation in our hospital, collect various preoperative biometric data and postoperative refractive data of patients, conduct statistical analysis, and compare the accuracy of various IOL calculation formulas.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Study on the Accuracy of Intraocular Lens Calculation Formula
Anticipated Study Start Date
:
Jan 1, 2023
Anticipated Primary Completion Date
:
Dec 1, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Outcome Measures
Primary Outcome Measures
- Mean absolute error [1 week、1 month and 3 months postoperation]
The Friedman test was applied to compare the median absolute error between the formulas after the zeroing of the mean numerical error. Post hoc analysis and Bonferroni correction was performed for multiple comparisons.
Secondary Outcome Measures
- Distribution of error within ± 0.25D, ± 0.5D, ± 0.75D,and ± 1.0D [1 week、1 month and 3 months postoperation]
Frequency comparisons were made with the chi-square test
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- (1) Conform to the diagnosis of cataract; (2) No complications occurred during and after operation; (3) Before and after operation, the measurement of ocular biological characteristics and refractive state can be successfully completed; (4) Patients who can be followed up regularly after operation.
Exclusion Criteria:
- (1) Serious intraoperative or postoperative complications; (2) Complicated with other eye diseases unsuitable for intraocular lens implantation; (3) Patients with systemic diseases cannot tolerate surgery; (4) Patients with incomplete follow-up data.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Study Chair: Wen Xu, Second Affiliated Hospital, Zhejiang University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05672693
Other Study ID Numbers:
- 2022-1059
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 5, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No