2024-511820-15-03CompletedPhase 4
Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. (SNAP)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 19 Nov 2024
- Start date
- 1 Aug 2019
- Lead sponsor
- Rigshospitalet
- Diseases
- Glaucoma
- EU CT number
- 2024-511820-15-03
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 72
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior intraocular surgery, except from cataract surgery
- Steroid responders
- Patients in systemic treatment with steroid or NSAID
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet | Glostrup | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.