A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.
详细描述
We believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. Its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina.
This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.
- •Central retinal thickness ≥ 250 μm.
- •Age more than 18 years old.
- •Decision makers able to give informed consent.
- •Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.
排除标准
- •Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).
- •Any other macular pathology that could affect anatomic or functional results.
- •History of uveitis requiring intravitreal triamcinolone injection.
- •History of steroid-responsive glaucoma.
- •History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).
- •IOP > 23 mm Hg if untreated, or > 21 mm Hg if treated with medication.
- •Pregnant or breast-feeding woman.
- •Unable to attend the scheduled follow-up appointments.
- •Patients with known hypersensitivity to any components of Ozurdex® or to other corticosteroids.
- •Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
研究组 & 干预措施
Ozurdex
Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane
干预措施: Ozurdex (Drug)
结局指标
主要结局
Best corrected visual acuity
时间窗: 3 Months
Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
次要结局
- Retinal thickness and volume(6 months)
- Best corrected visual acuity at 1,4 and 6 months(6 months)
- Intraocular pressure (IOP)(6 months)
- Cataract progression (if applicable)(6 months)