Evaluation of Primary Congenital Glaucoma at Asyut Univer... | NCT05205122

Studies
Evaluation of Primary Congenital Glaucoma at Asyut University Hospital

NCT05205122

Sponsor

Omar Abdelkarem Hasan

Status

Unknown status

Last Update Posted

Jan 24, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Primary Congenital Glaucoma

Interventions

Combined trabeculotomy-trabeculectomy with mitomycin C

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Estimated

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Jan 11, 2022

First Submission Date that Met QC Criteria

Jan 11, 2022

First Posted Date

Jan 24, 2022Actual

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 11, 2022

Last Update Posted Date

Jan 24, 2022Actual

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

Evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at Asyut University Hospital

Detailed Description

Not provided

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infants with primary congenital glaucoma	Experimental		Procedure: Combined trabeculotomy-trabeculectomy with mitomycin C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combined trabeculotomy-trabeculectomy with mitomycin C	Procedure	Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases	Infants with primary congenital glaucoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP follow up	postoperative measurment of Intra ocular pressure by shoitz tonometer	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Typical symptoms of epiphora , photophobia and blepharospasm Corneal diameter > 13 mm Increased ocular tension > 25 mmHg UGA using schiotz tonometer

Exclusion Criteria:

Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other congenital anomalies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omar Abdelkarem Hasan, M.B.B.Ch.	Contact	00201000525341		oabdelkarem@gmail.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006871	Hydrophthalmos

Ancestor Terms

ID	Term
D005124	Eye Abnormalities
D005128	Eye Diseases
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016685	Mitomycin

Ancestor Terms

ID	Term
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided