Iris Tissue in Primary Congenital Glaucoma

Histopathological Examination of Iris Tissue in Primary Congenital Glaucoma

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

Study Overview

• Status: Unknown
• Conditions: Primary Congenital Glaucoma
• Intervention / Treatment: Procedure: Combined trabeculotomy-trabeculectomy with mitomycin c

Detailed Description

Primary congenital glaucoma etiology still remains obscure . originally barkan , and later Worst , proposed that a membrane covered the anterior chamber angle and blocked aqueous outflow , but the presence of that membrane has not been established histopathologically to date . Now most authors believe that the site of obstruction is the trabecular meshwork rather than an overlying membrane . Maldevelopment of the anterior segment is present in all forms of congenital glaucoma . this maldevelopment may involve the trabecular meshwork alone or the trabecular meshwork in combination with the iris or cornea or both. In approcimately 50% of patients , isolated trabeculodysgensis is the only developmental ocular anomaly found .This is the classic defect found in primary congenital glaucoma .These eyes have no developmental anomalies of iris or cornea present except abnormal insertion of the iris into the angle

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Typical symptoms of epiphora , photophobia and blepharospasm
2. corneal diameter > 13 mm
3. Increased ocular tension > 25 mmHg UGA using schiotz tonometer

Exclusion Criteria:

1. Infants with history of previous surgery
2. Secondary glaucoma
3. Glaucoma associated with other congenital anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental : Infants with primary congenital glaucoma	Procedure: Combined trabeculotomy-trabeculectomy with mitomycin c; 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; Other Names: Histopathological examination of iris tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Ocular Pathology Atlas. American Academy of Ophthalmology Web site. https://www.aao.org/resident-course/pathology-atlas. Published 2016. Accessed January 4, 2017
• American Academy of Ophthalmology. Congenital glaucoma, cloudy corneas. https://www.aao.org/image/congenital-glaucoma-cloudy-corneas-2 Accessed July 01, 2019

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Glaucoma; Hydrophthalmos; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: primary congenital glaucoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No