Study on the Accuracy of Intraocular Lens Calculation Formula

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.

Study Overview

• Status: Recruiting
• Conditions: the Accuracy of Intraocular Lens Calculation Formula
• Intervention / Treatment: Other: Several Calculation Formulas of Intraocular Lens

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Wen Xu, PHD; Phone Number: 13858185223; Email: xuwen2003@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: wen xu; Phone Number: 13858185223; Email: xuwen2003@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who were previously diagnosed as "senile cataract" in the Ophthalmology Center of the Second Affiliated Hospital of Zhejiang University Medical College and who performed "phacoemulsification cataract extraction combined with intraocular lens implantation"

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute error	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.	1 week、1 month and 3 months postoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of error within ± 0.25D, ± 0.5D, ± 0.75D,and ± 1.0D	Frequency comparisons were made with the chi-square test	1 week、1 month and 3 months postoperation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Wen Xu, Second Affiliated Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-1059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No