Triamcinolone acetonide to prevent PVR in eyes undergoing vitreoretinal surgery for open globe trauma - AOT
Phase 1
- Conditions
- Proliferative vitreoretinopathy following open globe trauma.MedDRA version: 9.1 Level: LLT Classification code 10057896 Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2007-005138-35-GB
- Lead Sponsor
- Moorfields Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
An open globe injury requiring vitrectomy either following a primary globe repair or as the primary procedure itself.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) Glaucoma, ocular hypertension or steroid responsive glaucoma.
2) Previous vitrectomy.
3) Enrolment in other studies.
4) Inability to attend regular follow up.
5) Unable to give informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This is a pilot RCT to investigate the the effect of the use of peroperative intravitreal triamcinilone acetate in the development of proliferative vitreoretinopathy following open globe trauma.;Secondary Objective: ;Primary end point(s): The trial will end when all 40 patients have been reviewed 6 months following the peroperative treatment with triamcinolone. The trial will be terminated earlier if there is evidence that this treatment protocol is clearly inferior to the standard treatment.
- Secondary Outcome Measures
Name Time Method