Status:
UNKNOWN
Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy.
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Glaucoma
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
PURPOSE: Glaucoma is the leading cause of non-curable blindness globally. Patients with glaucoma will get a gradual narrowing of the visual fields caused by compression at the optic nerve head due to...
Eligibility Criteria
Inclusion
- Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) or 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
- Informed consent to participation and ability to comply with study procedures
Exclusion
- Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
- Prior intraocular surgery, except from cataract surgery. If cataract surgery has been performed, it should at least be 6 months prior to surgery
- Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma
- Steroid responders
- Pregnancy
- Fertile women, i.e. women who are not menopausal and women who breastfeed
- Patients in systemic treatment with steroid or NSAID
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04054830
Start Date
August 1 2019
End Date
July 1 2023
Last Update
October 26 2022
Active Locations (1)
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1
Department of Ophthalmology
Glostrup Municipality, Capital Region, Denmark, 2600