Glaucoma
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. Intervention Group (Triamcinolone): 19 participants diagnosed with refractory primary open-angle glaucoma (glaucoma that is diffi
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Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years or older; both genders; diagnosis of primary open-angle glaucoma refractory to maximally tolerated medical therapy and failure of at least one previous trabeculectomy surgery; indication for primary implantation of the Susanna UF glaucoma drainage device; best-corrected visual acuity in the study eye of light perception or better; ability to understand and sign the Informed Consent Form; availability to attend all study follow-up visits for a six-month period
Exclusion criteria
Exclusion criteria: No light perception visual acuity in the study eye; previous glaucoma drainage device surgery in the study eye; need for combined surgery at the time of Susanna UF drainage device implantation (e.g., phacoemulsification, pars plana vitrectomy); neovascular glaucoma; uveitic glaucoma; glaucoma following corneal transplantation; any ocular or systemic condition that, in the investigator's opinion, could prevent protocol-required examinations, interfere with outcome assessment, or significantly increase risk to the participant; concurrent participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to find a clinically significant difference in mean intraocular pressure (IOP) between the group receiving adjunctive subtenon triamcinolone and the control group at six months of follow-up. Verification would be performed by Goldmann applanation tonometry. A difference of at least 3 mmHg between the groups is expected, with a lower mean IOP in the triamcinolone group.;Found outcome 1: No statistically significant difference in mean IOP was observed at six months between the groups. The final mean IOP was 14.05 ± 3.99 mmHg in the control group and 14.33 ± 4.70 mmHg in the triamcinolone group (p > 0.99 for the between-group comparison). Verification was performed by Goldmann applanation tonometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It is expected to find a reduction in the incidence of the hypertensive phase (HP) in the triamcinolone group compared to the control group. Verification would be performed by recording IOP at all follow-up visits, with the finding of a lower proportion of patients developing HP (defined as IOP > 21 mmHg) in the triamcinolone-treated group.;Found outcome 2: No significant difference in the incidence of the hypertensive phase was observed between the groups. It was found, by recording IOP during follow-up, that 73.78% of the patients in the triamcinolone group and 75% of the patients in the control group experienced the hypertensive phase (p = 0.93).;Expected outcome 3: It is expected to find a lower need for hypotensive medications at six months postoperatively in the triamcinolone group compared to the control group. Verification would be performed by recording the number of hypotensive eye drops in use, with the expectation of a lower mean number in the triamcinolone group.;Found outcome 3: No significant difference in the need for hypotensive medications was observed between the groups at six months. It was found, by recording the number of eye drops, that the control group used a mean of 1.57 ± 1.73 medications and the triamcinolone group used a mean of 1.16 ± 1.43 medications (p = 0.95).;Expected outcome 4: It is expected to find a superior or equivalent surgical success rate, and a similar or lower incidence of complications, in the triamcinolone group compared to the control group. Verification would be performed by applying predefined success criteria (based on IOP and medication use) and by the prospective recording of all postoperative complications.;Found outcome 4: Qualified success rates were similar between the groups, being 90% in the control group and 89.47% in the triamcinolone group (Criterion I: IOP between 5-21 mmHg). However, a significantly higher incidence of serious complications (defined as late hypotony or malignant glau | — |
Countries
Brazil
Contacts
Public ContactMarcus Takatsu
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed