NCT04011878

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

July 4, 2019

Last Update Submit

July 4, 2019

Conditions

Iris Disease

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 month

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Iris Diseases

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Uveal DiseasesEye 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

July 4, 2019

First Posted

July 9, 2019

Study Start

January 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share