PERI-OPERATIVE PROPHYLAXIS FOR CATARCT SURGERY IN UVEITIC PATIENTS: A MULTICENTRIC, PROSPECTIVE, RANDOMISED STUDY - SAFE SURGERY IN UVEITIS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015037-78-IT

Enrollment

100

Registered

2009-10-01

Start date

2009-10-27

Completion date

Unknown

Last updated

2016-04-11

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

Conditions

PATIENTS AFFECTED BY CATARCT WITH HISTORY OF UVEITIS MedDRA version: 9.1 Level: PT Classification code 10007739

Interventions

Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Dexamethasone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical Form: Tablet INN or

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Major prior ocular surgery in the enrolled eye, poor compliance to topical steroids or steroid responder condition, secondary glaucoma under medical treatment.

Design outcomes

Primary

Measure	Time frame
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: -the foveal depth; -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	—

Measure

Time frame

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: -the foveal depth; -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

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026