NCT04079725

Brief Summary

To present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

August 30, 2019

Last Update Submit

October 20, 2020

Conditions

Primary Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis

    Histopathological features of iris tissue in infants with primary congenital glaucoma who underwent Combined trabeculotomy-trabeculectomy with mitomycin C

    2 years

Study Arms (1)

Experimental : 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 then histopathological examination of iris tissue to detect the nature of the disease

Also known as: Histopathological examination of iris tissue
Experimental : Infants with primary congenital glaucoma

Eligibility Criteria

Age7 Days - 1 Year
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

Related Publications (8)

  • Mandal AK, Naduvilath TJ, Jayagandan A. Surgical results of combined trabeculotomy-trabeculectomy for developmental glaucoma. Ophthalmology. 1998 Jun;105(6):974-82. doi: 10.1016/S0161-6420(98)96022-5.

    PMID: 9627644BACKGROUND

  • Suri F, Yazdani S, Narooie-Nejhad M, Zargar SJ, Paylakhi SH, Zeinali S, Pakravan M, Elahi E. Variable expressivity and high penetrance of CYP1B1 mutations associated with primary congenital glaucoma. Ophthalmology. 2009 Nov;116(11):2101-9. doi: 10.1016/j.ophtha.2009.04.045. Epub 2009 Sep 10.

    PMID: 19744731BACKGROUND

  • Biglan AW. Glaucoma in children: are we making progress? J AAPOS. 2006 Feb;10(1):7-21. doi: 10.1016/j.jaapos.2005.10.001.

    PMID: 16527674BACKGROUND

  • Black AC, Jones S, Yanovitch TL, Enyedi LB, Stinnett SS, Freedman SF. Latanoprost in pediatric glaucoma--pediatric exposure over a decade. J AAPOS. 2009 Dec;13(6):558-62. doi: 10.1016/j.jaapos.2009.10.003.

    PMID: 20006816BACKGROUND

  • Kargi SH, Koc F, Biglan AW, Davis JS. Visual acuity in children with glaucoma. Ophthalmology. 2006 Feb;113(2):229-38. doi: 10.1016/j.ophtha.2005.10.029. Epub 2006 Jan 10.

    PMID: 16406536BACKGROUND

  • Mandal AK, Gothwal VK, Bagga H, Nutheti R, Mansoori T. Outcome of surgery on infants younger than 1 month with congenital glaucoma. Ophthalmology. 2003 Oct;110(10):1909-15. doi: 10.1016/S0161-6420(03)00671-7.

    PMID: 14522762BACKGROUND

  • Ocular Pathology Atlas. American Academy of Ophthalmology Web site. https://www.aao.org/resident-course/pathology-atlas. Published 2016. Accessed January 4, 2017

    BACKGROUND

  • American Academy of Ophthalmology. Congenital glaucoma, cloudy corneas. https://www.aao.org/image/congenital-glaucoma-cloudy-corneas-2 Accessed July 01, 2019

    BACKGROUND

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

+201000525341oabdelkarem@gmail.com

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
Resident doctor

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 6, 2019

Study Start

December 1, 2020

Primary Completion

September 1, 2021

Study Completion

March 1, 2022

Last Updated

October 22, 2020

Record last verified: 2020-10