Iris Tissue in Primary Congenital Glaucoma

NCT ID: NCT04079725

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2022-03-31

Brief Summary

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

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

Conditions

Primary Congenital Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental : Infants with primary congenital glaucoma

Group Type: EXPERIMENTAL

Combined trabeculotomy-trabeculectomy with mitomycin c

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Histopathological examination of iris tissue

Eligibility Criteria

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Abdelkarem Hasan

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

oabdelkarem@gmail.com

+201000525341

References

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.

Reference Type: BACKGROUND

PMID: 9627644 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19744731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16527674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20006816 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16406536 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14522762 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

primary congenital glaucoma

Identifier Type: -

Identifier Source: org_study_id