Iris Tissue in Primary Congenital Glaucoma

Primary Congenital Glaucoma Clinical Trial

Official title:

Histopathological Examination of Iris Tissue in Primary Congenital Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04079725
• Other study ID #: primary congenital glaucoma
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: March 2022

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: Omar Abdelkarem Hasan, M.B.B.Ch.
• Phone: +201000525341
• Email: oabdelkarem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Primary Congenital Glaucoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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

Biglan AW. Glaucoma in children: are we making progress? J AAPOS. 2006 Feb;10(1):7-21. Review. — View Citation

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. — View Citation

Kargi SH, Koc F, Biglan AW, Davis JS. Visual acuity in children with glaucoma. Ophthalmology. 2006 Feb;113(2):229-38. Epub 2006 Jan 10. — View Citation

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. — View Citation

Mandal AK, Naduvilath TJ, Jayagandan A. Surgical results of combined trabeculotomy-trabeculectomy for developmental glaucoma. Ophthalmology. 1998 Jun;105(6):974-82. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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