Trial of intra-operative adjuvant mytomycin C versus 5-Fluorouracil with trabeculotomy-trabeculectomy for developmental glaucoma
Not Applicable
- Conditions
- Eye DiseasesSurgeryPaediatricsDevelopmental Glaucomas
- Registration Number
- PACTR201312000712328
- Lead Sponsor
- Office of Research, Innovation and Development (ORID), University of Ghana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
All cases of developmental glaucoma with or without a previous history of glaucoma surgery, aged less than 16 years,
with written informed consents from their parents/ guardians
Exclusion Criteria
All children with traumatic glaucoma,
drug related (steroid- induced) glaucoma, aphakic glaucoma,
inflammatory glaucoma,
glaucoma associated with ocular tumours and other causes of non-developmental glaucomas
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surgical success is defined as: Intraocular Pressure (IOP) ¿21mmHg without anaesthesia and IOP¿16mmHg under general anaesthesia, stable corneal diameter and clear cornea, stable optic disc cupping and stable visual fields (in older children)
- Secondary Outcome Measures
Name Time Method Visual outcome;surgical complications;drug reactions / complications