Long Term Evaluation of Primary Congenital Glaucoma Manag... | NCT04949555

Studies
Long Term Evaluation of Primary Congenital Glaucoma Management in Sohag University Hospital

NCT04949555

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Feb 9, 2022Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Primary Congenital Glaucoma

Interventions

Primary congenital glaucoma evaluation

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

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 1, 2021Actual

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Jun 16, 2021

First Submission Date that Met QC Criteria

Jun 24, 2021

First Posted Date

Jul 2, 2021Actual

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

Feb 8, 2022

Last Update Posted Date

Feb 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ghada Fathy Mohamed, resident practitioner of ophthalmology.principal investigator, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

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

evaluation of primary congenital glaucoma management in sohag university hospital

Detailed Description

long term evaluation of primary congenital glaucoma management in sohag university hospital

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

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Primary congenital glaucoma evaluation	Other	long term evaluation of primary congenital glaucoma management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of patient with primary congenital glaucoma managed in sohag university hospital by surgical intervention,trabeculectomy and trabecultomy with mitomycin and ologen.follow up after management by measuring intra ocular pressure by Perkins.	retrospective study	3years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children operated more than 3 months

Exclusion Criteria:

other types of operated pediatric glaucoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patient s with primary congenital glaucoma operated in sohag university hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ghada f mohamed, MBBCH	Contact	01004720821	sohag	ghada_fathy_post@med.sohag.edu.eg

Overall Officials

Name	Affiliation	Role
ghada f mohamed, MBBCH	Sohag University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghada Fathy Mohamed	Recruiting	Sohag			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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 22, 2021	Jun 24, 2021	Prot_000.pdf

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