Iris Tissue in Primary Congenital Glaucoma
Primary Purpose
Primary Congenital Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined trabeculotomy-trabeculectomy with mitomycin c
Sponsored by
About this trial
This is an interventional treatment trial for Primary Congenital Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Typical symptoms of epiphora , photophobia and blepharospasm
- corneal diameter > 13 mm
- Increased ocular tension > 25 mmHg UGA using schiotz tonometer
Exclusion Criteria:
- Infants with history of previous surgery
- Secondary glaucoma
- Glaucoma associated with other congenital anomalies
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental : Infants with primary congenital glaucoma
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04079725
Brief Title
Iris Tissue in Primary Congenital Glaucoma
Official Title
Histopathological Examination of Iris Tissue in Primary Congenital Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Congenital Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental : Infants with primary congenital glaucoma
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Combined trabeculotomy-trabeculectomy with mitomycin c
Other Intervention Name(s)
Histopathological examination of iris tissue
Intervention Description
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
Primary Outcome Measure Information:
Title
Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis
Description
Histopathological features of iris tissue in infants with primary congenital glaucoma who underwent Combined trabeculotomy-trabeculectomy with mitomycin C
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Typical symptoms of epiphora , photophobia and blepharospasm
corneal diameter > 13 mm
Increased ocular tension > 25 mmHg UGA using schiotz tonometer
Exclusion Criteria:
Infants with history of previous surgery
Secondary glaucoma
Glaucoma associated with other congenital anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Abdelkarem Hasan, M.B.B.Ch.
Phone
+201000525341
Email
oabdelkarem@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
9627644
Citation
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.
Results Reference
background
PubMed Identifier
19744731
Citation
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.
Results Reference
background
PubMed Identifier
16527674
Citation
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.
Results Reference
background
PubMed Identifier
20006816
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.
Results Reference
background
PubMed Identifier
16406536
Citation
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.
Results Reference
background
PubMed Identifier
14522762
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. doi: 10.1016/S0161-6420(03)00671-7.
Results Reference
background
Citation
Ocular Pathology Atlas. American Academy of Ophthalmology Web site. https://www.aao.org/resident-course/pathology-atlas. Published 2016. Accessed January 4, 2017
Results Reference
background
Citation
American Academy of Ophthalmology. Congenital glaucoma, cloudy corneas. https://www.aao.org/image/congenital-glaucoma-cloudy-corneas-2 Accessed July 01, 2019
Results Reference
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Iris Tissue in Primary Congenital Glaucoma
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