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Befejeződött4. fázis

Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. (SNAP)

Key facts

Where
Glostrup, DániaSee the site
Phase
4. fázis

Where in Dánia

  • RigshospitaletGlostrup, DániaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Rigshospitalet
Trial code
EU 2024-511820-15-03
Record updated
2024. november 29.
Original description
The purpose of this study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids or a combination of the two and to explore the mechanisms behind the pathophysiology of glaucoma. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.Read full original descriptionShow less

The purpose of this study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids or a combination of the two and to explore the mechanisms behind the pathophysiology of glaucoma. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.

Inclusion: Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) and ocular hypertension; >50 years; Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months; Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark; Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study; Informed consent to participation and ability to comply with study procedures.

Exclusion: Prior intraocular surgery, except from cataract surgery; Steroid responders; Patients in systemic treatment with steroid or NSAID; Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study; Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma; Pregnancy; Fertile women, i.e. women who are not menopausal and women who breastfeed; Patients who are excluded due to perioperative complications will not provide data for the study.

EU CTIS 2024-511820-15-03