To investigate the optimal medical treatment after glaucoma surgery to achieve pressure drop in the eye.
- Conditions
- Medically uncontrolled glaucoma that requires filtration surgery.MedDRA version: 20.0 Level: LLT Classification code 10018326 Term: Glaucoma NOS System Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2018-001855-10-DK
- Lead Sponsor
- Department of Ophtalmology, Rigshospitalet-Glostrup
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 75
INCLUSION CRITERIA
•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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
EXCLUSION CRITERIA
•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
•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 who are excluded due to perioperative complications will not provide data for the study.
•Patients in systemic treatment with steroid or NSAID
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.;Timepoint(s) of evaluation of this end point: 12 months after surgery
- Secondary Outcome Measures
Name Time Method