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Use of subtenon triamcinolone acetonide for a dropless trabeculectomy surgery

Safety and efficacy of dropless steroid trabeculectomy surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13866013
Enrollment
58
Registered
2023-01-20
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

Pseudophakic patients undergoing trabeculectomy surgery Surgery

Interventions

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 besid
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 operate

Sponsors

Nova Scotia Health Authority
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 21 mmHg or pressure reduction lower than 20% compared to baseline) during the duration of the study

Countries

Canada

Outcome results

None listed

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