Trial of intra-operative adjuvant mytomycin C versus 5-Fluorouracil with trabeculotomy-trabeculectomy for developmental glaucoma

Randomised Controlled Trial of intra-operative adjuvant mytomycin C versus 5-Fluorouracil with trabeculotomy-trabeculectomy for developmental glaucomas

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201312000712328

Enrollment

Registered

2013-11-23

Start date

2009-06-11

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases Surgery Paediatrics Developmental Glaucomas

Interventions

Combined trabeculectomy- trabeculotomy

Combined trabeculectomy-trabeculotomy + intraoperative Mytomicin C

Combined trabeculectomy- trabeculotomy + intraoperative 5 Fluorouracil

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Visual outcome;surgical complications;drug reactions / complications	—

Countries

Ghana

Contacts

Public ContactImelda-O. Dzifa Ofori Adjei

Ophthalmologist / Co-Investigator

dziffabella@gmail.com+ 233 206301838

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026