Trabeculectomy With MMC and I Stent in Uveitic Glaucoma a... | NCT03293251

Studies
Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors

NCT03293251

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 26, 2017Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Outcomes of Trabeculectomy With MMC

Interventions

Trabeculectomy with MMC

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

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Oct 29, 2018Estimated

Completion Date

Dec 29, 2018Estimated

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Sep 24, 2017

First Posted Date

Sep 26, 2017Actual

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

Sep 24, 2017

Last Update Posted Date

Sep 26, 2017Actual

Name	Class
The Queen Elizabeth Hospital	OTHER

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

determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not.
Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.
recurrence rate of uveitis after glaucoma surgery

Detailed Description

determine different success rates of trabeculectomy with MMC undergone in QE hospital, UK.
determine different complications and effect of cataract surgery on the outcome of glaucoma surgery

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
uveitic/ POAG		Outcomes, success rates, complications of trabeculectomy with MMC in Uveitic glaucoma	Procedure: Trabeculectomy with MMC
POAG		Outcomes, success rates, complications of trabeculectomy with MMC and I stent in this groups	Procedure: Trabeculectomy with MMC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trabeculectomy with MMC	Procedure	glaucoma surgeries	POAG uveitic/ POAG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rates	IOP less 21 mmHg	5 year period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fesh trabeculectomy surgeries

Exclusion Criteria:

recurrent surgeries

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

cohort of patient documented on the database system of Queen Elizabeth hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Kamel Soliman, professor	Assiut University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maha Said		Egypt	Asyut Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

undecided yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014130	Trabeculectomy

Ancestor Terms

ID	Term
D018463	Filtering Surgery
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided