Steroids and Non-steroidal Anti-inflammatory drugs in the Postoperative regime after trabeculectomy. An investigator-initiated randomized study (The SNAP study)

Department of Ophtalmology, Rigshospitalet-Glostrup0 个研究点目标入组 75 人开始时间: 2018年9月3日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•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
•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

发起方

Department of Ophtalmology, Rigshospitalet-Glostrup