Study on the Accuracy of Intraocular Lens Calculation For... | NCT05672693

Studies
Study on the Accuracy of Intraocular Lens Calculation Formula

NCT05672693

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jan 5, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

the Accuracy of Intraocular Lens Calculation Formula

Interventions

Several Calculation Formulas of Intraocular Lens

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jan 3, 2023

First Submission Date that Met QC Criteria

Jan 3, 2023

First Posted Date

Jan 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2023

Last Update Posted Date

Jan 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Several Calculation Formulas of Intraocular Lens	Other	Comparison of the accuracy of several intraocular lens calculation formulas

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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"

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen Xu, PHD	Contact	13858185223		xuwen2003@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Wen Xu	Second Affiliated Hospital, Zhejiang University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital, Zhejiang University School of Medicine	Recruiting	Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided