se of auxiliary Triamcinolone acetonide in glaucoma surgery: a clinical trial

Not Applicable

• Conditions: Glaucoma; C11.525.381

• Registration Number: RBR-53f8nh
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Both genders; diagnosis of clinically uncontrolled non-inflammatory glaucomas with indication of trabeculectomy.

Exclusion Criteria

Diagnosis of inflammatory glaucomas (neovascular and uveitic glaucoma); Diagnosis of glaucomas with associated clinically relevant cataracts, and indication of combined surgery; Previous intraocular surgery, except for uncomplicated phacoemulsification or laser surgery performed more than 6 months prior to glaucoma surgery.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rates of intraocular pressure control during the postoperative follow-up period of the glaucoma sugeries. Evaluated as intraocular pressure measurements at 6, 12, 18 and 24 months postop, considering reference values: <18mmHg (criterion 1) and 15 mmHg (criterion 2). Analysis performed with survival analysis and log-rank test.

Secondary Outcome Measures

Name	Time	Method
Outcome 1: differences in intraocular pressure values between groups in the postoperative period.Analysis performed with independent t test.;Outcome 2: differences in the number of hypotensive eyedrops (measured as number of medications in use) between groups in the postoperative period. Analysis performed with independent t test.;Outcome 3: differences in the number of postoperative surgical complications (measured as frequency of each complication) between groups. Analysis performed with independent t test.;Outcome 4: differences in the need for reoperation rates (measured as frequency of need for reoperation) between groups in the postoperative period. Analysis performed with independent t test.