NCT05205122

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

January 11, 2022

Last Update Submit

January 11, 2022

Conditions

Primary Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

  • IOP follow up

    postoperative measurment of Intra ocular pressure by shoitz tonometer

    1 year

Study Arms (1)

Infants with primary congenital glaucoma

EXPERIMENTAL
Procedure: Combined trabeculotomy-trabeculectomy with mitomycin C

Interventions

Combined trabeculotomy-trabeculectomy with mitomycin CPROCEDURE

Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases

Infants with primary congenital glaucoma

Eligibility Criteria

Age1 Day - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hydrophthalmos

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesGlaucoma, Open-AngleGlaucomaOcular HypertensionCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Omar Abdelkarem Hasan, M.B.B.Ch.

CONTACT

00201000525341oabdelkarem@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 24, 2022

Study Start

February 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

January 24, 2022

Record last verified: 2022-01