Anterior Segment Changes After Phacoemulsification in Cat... | NCT06745596

Studies
Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber

NCT06745596

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

cataract surgery 1
cataract surgery 2

Countries

Egypt

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

ID	Type	Description	Link
Zagazig university	Other Identifier	Zagazig university

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2022Actual

Primary Completion Date

Feb 2, 2024Actual

Completion Date

Jun 24, 2024Actual

First Submitted Date

Dec 6, 2024

First Submission Date that Met QC Criteria

Dec 18, 2024

First Posted Date

Dec 20, 2024Actual

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

Dec 18, 2024

Last Update Posted Date

Dec 20, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps. This study aimed to compare the efficacy of combined phacoemulsification with limited pars plana vitrectomy versus phacoemulsification alone in cases with shallow anterior chamber.

Methods: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cataract with limited anterior pars plana vitrectomy	Active Comparator	group I included twelve patients who underwent phacoemulsification combined with limited anterior pars plana vitrectomy	Procedure: cataract surgery 1
Cataract without limited anterior pars plana vitrectomy	Active Comparator	group II included twelve patients that underwent phacoemulsification only	Procedure: cataract surgery 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery 1	Procedure	Cataract with limited anterior pars plana vitrectomy	Cataract with limited anterior pars plana vitrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central corneal thickness in micrometers.	Central corneal thickness in both groups measured by anterior segment OCT	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Anterior chamber depth of less than 2.8 mm associated with cataract

Exclusion Criteria:

Mature cataract
History of previous ocular surgery
Posterior segment pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Mohammad Gamal Mohammad Gamal, MBBCh	Zagazig University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig University		Zagazig	Sharqia Province	44511	Egypt

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

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases