NCT07034651

Brief Summary

To revise the etiology of the primary congenital glaucoma in some infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 14, 2025

Last Update Submit

June 14, 2025

Conditions

Iris Diseases

Keywords

iris tissue, buphthalmos

Outcome Measures

Primary Outcomes (1)

  • fibrovascular membrane over iris surface

    angle closure by a fibrovascular tissue proliferation over the trabecular meshwork in the anterior chamber angle

    6 months

Study Arms (1)

isolated trabeculodysgensis

EXPERIMENTAL

etiology of primary congenital glaucoma

Procedure: Combined trabeculotomy trabeculectomy with mitomycin C

Interventions

Combined trabeculotomy trabeculectomy with mitomycin CPROCEDURE

Combined trabeculotomy trabeculectomy with mitomycin C with histopathological examination of the peripheral iris tissue specimen of all cases

isolated trabeculodysgensis

Eligibility Criteria

Age1 Month - 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants under age of 2 years
  • ery glaucoma

You may not qualify if:

  • infants more than 2 years
  • ery glaucoma
  • previous glaucoma surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut univercity

Asyut, Egypt

Location

MeSH Terms

Conditions

Iris DiseasesHydrophthalmos

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesEye AbnormalitiesGlaucoma, 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

June 14, 2025

First Posted

June 24, 2025

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations

EG(1)