ISRCTN22626706进行中（未招募）Unknown
A feasibility study: The efficacy and safety of heat applied to closed eyelids in enhancing the delivery of ocular hypotensive eye drops in the treatment of primary open-angle glaucoma
orth West Anglia NHS Foundation Trust0 个研究点目标入组 24 人开始时间: 2023年9月27日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent signed and dated
- •2. Patients diagnosed with bilateral primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
- •3. Patient aged =18 years old
- •4. Both eyes with a central corneal thickness of between 500-600 µm
- •5. Both eyes with a diagnosis of POAG or OHT, initially treated and controlled for at least six months by a prostaglandin analogue monotherapy (mane instillation)
- •6. IOP = 24 mmHg in at least one eye POAG
- •7. IOP = 30 mmHg in at least one eye OHT
排除标准
- •1. Fundus examination not performed or not available within 12 months
- •2. Visual field not performed or not available within 12 months
- •3. Advanced stage of glaucoma, defined by at least one of the following criteria:
- •4. Absolute defect in the ten degrees central point of the visual fields
- •5. Severe visual field loss: MD < -18 dB
- •6. Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgment
- •7. Far best corrected visual acuity = +0.7 logMAR
- •8. History of trauma, infection, clinically significant inflammation within the previous three months
- •9. Ongoing or known history of ocular allergy and/or uveitis and/or viral infection
- •10. Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment)
- •11. Conjunctival hyperaemia (Grade 5 - Efron scale)
- •12. Superficial punctate keratitis (Grade 4/5 – Oxford scale)
- •13. Blepharitis (Grade 3 – Efron scale)
- •14. Severe dry eye as assessed by the investigator
- •15. Corneal ulceration
- •16. Any palpebral abnormality incompatible with a good examination
- •17. Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination.
- •18. A patient judged to have poor compliance with their glaucoma drops according to the investigator’s best judgement
研究者
相似试验
已完成
不适用
To check the Safety and Effectiveness of Hair Fall Control Shampoo in Healthy Adult Human Subjects with Hair Fall ComplaintsCTRI/2022/08/044868Vasu Healthcare Private Limited Vasu Research Centre32
已完成
不适用
To assess the Safety and Effectiveness of Hair Growth Promoting Product in Healthy Adult Human Subjects with Hair Fall ComplaintsCTRI/2022/11/047330Anveya Living Private Limited29
已完成
不适用
To determine the safety and effectiveness of Hair Fall Control Oil Shots in hair fall reduction in Healthy Adult Human Subjects with Hair FallCTRI/2022/04/041710Brillare Science Private Limited16
已完成
不适用
A Pilot Study to Evaluate Safety and Efficacy of HLA-mismatched Granulocyte Transfusions in the Treatment of Patients with Solid Malignant Tumors Who Are Resistant to Standard Cancer Therapy or for Whom No Standard Cancer Therapy ExistsCTRI/2012/11/003116Munogenics Inc USA22
已完成
不适用
Study to evaluate the safety and feasibility of the STENTYS Balloon Delivery System (STENTYS-BDS).Coronary artery stenosiscoronary atherosclerosis1001108210007593NL-OMON41177STENTYS20