Effect of Dry Eye Disease on Accuracy of Intraocular Lens... | NCT07525336

Studies
Effect of Dry Eye Disease on Accuracy of Intraocular Lens Power Calculation Before Phacoemulsification

NCT07525336

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Dry Eye Disease (DED)
Cataract (Post-operative Cataract Surgery Follow-up)

Interventions

dry eye disease optimization

Countries

Not provided

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

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2026Estimated

Primary Completion Date

Apr 30, 2028Estimated

Completion Date

Apr 30, 2029Estimated

First Submitted Date

Apr 7, 2026

First Submission Date that Met QC Criteria

Apr 7, 2026

First Posted Date

Apr 13, 2026Actual

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

Apr 7, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This study aims to determine the effect of dry eye disease on intraocular lens power calculation and the postoperative refractive outcome.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dry eye disease		dry eye disease patients who are not optimized before phacoemulsification
non dry eye disease		non dry eye disease patients before phacoemulsification	Procedure: dry eye disease optimization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dry eye disease optimization	Procedure	dry eye disease management prior to obtaining intraocular lens power calculation	non dry eye disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare mean absolute error (MAE) between patients with and without DED		2 yeras
Compare mean absolute error (MAE) between patients with and without DED		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age equals to or above 40 years old
cataract patient
suitable for phacoemulsification
clear corneal media

Exclusion Criteria:

previous corneal surgery
advanced glaucoma
corneal pathology (keratoconus, scarring)
retinal disease affecting vision
irregular astigmatism
contact lens use within the last 2 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will consist of adult patients aged 40 years and older diagnosed with cataract and scheduled for phacoemulsification surgery at Assiut University Hospital.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Ziad M.A Sayed	Contact	+201152373413		mkkh30@gmail.com

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes
D002386	Cataract

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D007905	Lens Diseases

Browse Leaves

Not provided

Browse Branches

Not provided