PERI-OPERATIVE PROPHYLAXIS FOR CATARCT SURGERY IN UVEITIC PATIENTS: A MULTICENTRIC, PROSPECTIVE, RANDOMISED STUDY - SAFE SURGERY IN UVEITIS
- Conditions
- PATIENTS AFFECTED BY CATARCT WITH HISTORY OF UVEITISMedDRA version: 9.1Level: PTClassification code 10007739
- Registration Number
- EUCTR2009-015037-78-IT
- Lead Sponsor
- DR. PAOLO MORA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
History of anterior uveitis, possibly associated with vitritis, diagnosed in patients with: rheumatoid arthritis, juvenile idiopathic arthritis, Reiters syndrome, Crohns disease and other inflammatory bowel diseases, defined and undefined connective tissue diseases.
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
Major prior ocular surgery in the enrolled eye, poor compliance to topical steroids or steroid responder condition, secondary glaucoma under medical treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: It estimates the relapse of uveitis up to 180 days after cataract extraction in patients with history of non-infectious uveitis. They will be divided into two groups: group A undergoing topical steroidal prophylaxis, and group B undergoing oral steroidal prophylaxis.;Secondary Objective: Measuring at fixed time points in each treatment group:<br>-the foveal depth;<br>-the best corrected visual acuity.;Primary end point(s): The decrease of the uveitis relapsing rate of at least 30% in one of the treatment groups
- Secondary Outcome Measures
Name Time Method