se of subtenon triamcinolone acetonide for a dropless trabeculectomy surgery

Not Applicable

• Conditions: Surgery; Pseudophakic patients undergoing trabeculectomy surgery

• Registration Number: ISRCTN13866013
• Lead Sponsor: ova Scotia Health Authority

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-20
• Last Update Posted: 30 January 2023
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Age 18 to 90 years old
2. Patients selected for trabeculectomy surgery
3. Pseudophakic patients or patients that will do a combined procedure with filtration glaucoma surgery and will become pseudophakic
4. Ability to comprehend the study procedures

Exclusion Criteria

1. Unwilling or unable to give consent
2. Unable to come for scheduled postoperative visits
3. Patients that are known to be steroid responders (ocular hypertension with steroid use)
4. Presence of a condition that could affect inferior conjunctiva
5. Intraoperative complications: such as excessive hyphema, inability to perform a trabeculectomy flap, positive seidel, or posterior capsular rupture.
6. Pregnant or nursing women
7. No light perception vision
8. Active iris neovascularization or active proliferative retinopathy
9. Vitreous in the anterior chamber for which a vitrectomy is anticipated.
10. Previous cyclodestructive procedures, scleral buckling procedures, or silicone oil present
11. Conjunctival scarring precluding a trabeculectomy superiorly
12. Previous trabeculectomy or tube-shunt implantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients in the triamcinolone follow-up group that did not need steroid drops, recorded at the end of the study

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mean intraocular pressure (IOP) measured using applanation tonometry at follow-up visits at 1, 3, 6 months and 1 year after the surgery<br> 2. The number of pressure-reducing drops measured using chart review at 3, 6, and 12 months after the surgery<br> 3. Time to failure, defined by the need for any surgery for hypotony (pressure <5 mmHg) or for reducing pressure (IOP >21 mmHg or pressure reduction lower than 20% compared to baseline) during the duration of the study<br>