2024-518807-23-00招募中4 期
Comparing postoperative recovery after vitrectomy using NSAID eyedrops versus steroid eyedrops
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of an increase of at least 10 mmHg in IOP compared to baseline measured at week 2 and week 8.
研究概览
简要总结
To prove a reduced occurrence of post-operative increased intra-ocular pressure when using NSAID drops instead of steroid drops after vitrectomy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age planned for vitrectomy for macular surgery (macular pucker, vitreomacular traction, macular hole) with/without phaco-emulsification
- •Female participants must be either postmenopausal (no menses for ≥12 consecutive months without alternative medical cause) or surgically sterile (e.g., bilateral oophorectomy or hysterectomy).
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
排除标准
- •Participant has a history of other retinal disease that may affect the formation of macular edema
- •Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- •Ocular hypertension (IOP > 21 mmHg) and/or glaucoma
- •Systemic steroid or NSAID or immunosuppressant use
- •Recent intra-ocular surgery (phaco-emulsification) < 6 months
- •Previous vitrectomy surgery in study eye
- •Women of childbearing potential , defined as sexually mature females who have not undergone sterilization or are not postmenopausal as per above definition.
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- •Hypersensitivity towards diclofenac and one of the excipients of the finished product
结局指标
主要结局
Incidence of an increase of at least 10 mmHg in IOP compared to baseline measured at week 2 and week 8.
Incidence of an increase of at least 10 mmHg in IOP compared to baseline measured at week 2 and week 8.
次要结局
- Amount and grading of macular oedema on OCT at month 2 and 6 after surgery: - Presence or absence of intra-retinal cysts - Ratio of (Pre-op subfoveal thickness – Post-op thickness) / Pre-op thickness
- Amount of intra-ocular inflammation measured using laser flare photometry at day 3 (+/_ 2 days), week 2 and week 8.
研究者
Ophthalmology department information desk
Scientific
UZ Leuven
研究点 (1)
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