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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02121171 |
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Date of registration:
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19/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combined Trab+Trab Versus Combined Trab+Trab With Subconjunctival Implantation of Ologen for Primary Congenital Glaucoma
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Scientific title:
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Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma. |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02121171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Azerbaijan
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Contacts
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Name:
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Nigar Makhmudova |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ophthalmologist at National Centre of Ophthalmology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11
mm and intra-ocular pressure above 21 mmHg, including corneal edema or Haab's stria
with or without optic disc cupping.
Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic
abnormalities.
Within the age of (0 - 12).
Exclusion Criteria:
- Cases of congenital glaucoma with previous intervention. Age above 12 Yrs. Cases with
secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications
or trauma
Age minimum:
6 Months
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Congenital Glaucoma
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Intervention(s)
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Procedure: Combined trabeculotomy-trabeculectomy
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Device: Ologen Collagen Matrix
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Primary Outcome(s)
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Intraocular pressure(IOP) reduction
[Time Frame: At postoperative up to 24 months]
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Secondary Outcome(s)
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Postoperative complications and appearances.
[Time Frame: At postoperative up to 24 months.]
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Secondary ID(s)
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Trab+Trab+Ologen
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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