2024-511820-15-03
已完成
4 期
Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. (SNAP)
概览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.
概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) and ocular hypertension
- •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
排除标准
- •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
结局指标
主要结局
The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.
The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.
次要结局
- Postoperative intraocular pressure at 24 months
- Best corrected visual acuity (logMAR) at 12 and 24 months
- Changes in visual field at 12 and 24 months
- Optical nerve damage assessed by measuring retinal nerve fiber layer thickness (RNFL) by peripapillary optical coherence tomography (OCT) at 12 and 24 months
- Lens evaluation at, 12- and 24 months by pentacam
- Bleb morphology at 12 and 24 months
- Surgical success at 12 and 24 months
研究者
Øjenforskningen – Center for forskning i Øjensygdomme
Scientific
Rigshospitalet
研究点 (1)
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