Use of subtenon triamcinolone acetonide for a dropless trabeculectomy surgery

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: After providing informed consent, all participants will follow the same pre‐operative course as a regular patient undergoing glaucoma filtration surgery. They will receive no postoperative drops besides their regular glaucoma medication, and surgery will be scheduled on the date available for their glaucoma surgeon. On the day of the surgery, the surgeon will do the surgery as initially scheduled. If no complications occur, the patient will be randomized to either regular postoperative drops or sub‐tenon triamcinolone treatment. Randomization: At the baseline visit, after the patient agrees to participate in the study, the surgeon performing the filtrating surgery will talk with the nurse or nurse assistant to randomize a number at the website "random.org". If the number is even, the surgeon will do a TAC injection (triamcinolone follow‐up); if the number is odd, the surgeon will not do a TAC injection (regular follow‐up). 1. Prednisolone acetate 1% or dexamethasone sodium phosphate 0.1% drops every 2 hours on the operated eye for 1 month, followed by a tapper reducing a drop a day every 2 weeks until no drops are used. 2. Triamcinolone acetonide 16 mg (4 ml of the 40 mg/ml solution) injected subtenon at the time of the surgery. Both groups will be followed until the 1 year of follow‐up. The recorded follow‐up visits will be done on 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year after surgery. Doctors are free to schedule more follow‐up dates if necessary. CONDITION: Pseudophakic patients undergoing trabeculectomy surgery ; Surgery PRIMARY OUTCOME: 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: 1. Mean intraocular pressure (IOP) measured using applanation tonometry at follow‐up visits at 1, 3, 6 months and 1 year after the surgery; 2. The number of pressure‐reducing drops measured using chart review at 3, 6, and 12 months after the surgery; 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 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
Epistemonikos ID: 4471ed27f00081eaf5c71c710eeb4f9b34eab942
First added on: Feb 20, 2024