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临床试验/NCT04089033
NCT04089033已完成不适用

Retinal Displacement After Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2018年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
204
试验地点
1
主要终点
Retinal Displacement

研究概览

简要总结

This is a prospective cohort study, comparing the functional outcomes and the retinal displacement rates between two techniques for primary rhegmatogenous retinal detachment repair: Pars Plana Vitrectomy (PPV) and Pneumatic Retinopexy (PnR).

详细描述

Rhegmatogenous retinal detachment (RRD) is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 people.

Without surgical intervention by a vitreoretinal surgeon, retinal detachment almost invariably results in permanent sight loss in the affected eye. There is an increased risk of delayed visual rehabilitation the longer the wait for surgery. Both of the treatments under investigation are widely used and accepted by vitreoretinal surgeons.

Interventions for retinal detachment:

  1. Pneumatic retinopexy (PnR) has been employed to repair retinal detachments since the late 1980s and is a minor surgical intervention, carried out in a treatment room. The initial success rate (i.e. the proportion of patients in whom the retina becomes attached after one treatment) is quoted as approximately 70%. PnR is carried out under topical or local anaesthetic (a freezing injection under the conjunctiva, the superficial skin on the eye). The procedure involves injection of a small gas bubble into the eyeball via a fine needle. This step takes a maximum of 15 minutes. Two gases can be injected into the eye: perfluoropropane (C3F8), which lasts 6 weeks, and sulfahexafluoride (SF6), which lasts about 2 weeks. Both are non-toxic, equally effective, have been validated for this use, and are widely used amongst retina surgeons in the world. After injection of the gas bubble, the patient is required to maintain a strict 'head posture' (for example, head tilt to left) for up to 10 days. The purpose of this 'head posture' is to align the gas bubble (which floats within the eye) to the retinal tear. The buoyant force of the gas bubble, as well as its surface tension, act to reattach the detached retina over several days. The gas bubble spontaneously dissipates after 2-6 weeks, depending on the gas selected. Additionally, laser treatment or cryotherapy is carried out either before or 1-2 days after injection of the gas bubble, to secure the retinal tear. Both laser and cryotherapy are widely accepted methods of securing the tears in the retina and both are considered equally safe and effective. In patients where the retina does not reattach with PnR alone, vitrectomy surgery (PPV) or repeat PnR is needed (see below). However, the minority of patients who go on to need repeat treatment encounter similar final anatomical success rates and will experience the same gain in vision as those patients who underwent PPV in the first place.
  2. Vitrectomy surgery (PPV) involves 'keyhole' surgery to the eyeball, via three tiny (23/25 gauge) incisions to the sclera. This procedure is carried out in the operating room, under regional anaesthetic plus sedation. During PPV, the vitreous gel is removed from the eye using a fine metal instrument called a 'vitrector'. A large gas bubble (same gases as mentioned for PnR) is injected (to reattach the retina, as in PnR), and laser or cryotherapy is applied around the retinal tear to secure it (as in PnR). After treatment, the patient will be required to maintain a 'head posture' (face down for 24 hours). The gas bubble reabsorbs after 2-6 weeks, depending on the gas selected. The surgery takes 1-1.5 hours. The success rate (i.e. the proportion of patients in whom the retina becomes attached after one treatment) is reported as being as high as 90% in the scientific literature.

Both of the treatments may be associated with complications such as bleeding, infection, increased intraocular pressure or cataract. The risk of a sight threatening complication such as a severe intraocular infection or hemorrhage is less than 1:1000 (for both procedures). The risk of cataract development (clouding of the lens, requiring cataract extraction surgery) is less than 10% for PnR and at least 70% for PPV.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of macula off primary rhegmatogenous retinal detachment

排除标准

  • Previous retinal detachment and/or retinal detachment repair surgery in the study eye
  • Retinal detachment with macula on.
  • Patients with other retinal pathologies causing structural changes to the retina in the study eye, such as diabetic retinopathy, previous vascular occlusion (artery or vein occlusion), macular dystrophy, among others.
  • Previous vitreoretinal surgery in the study eye
  • Inability to come for follow ups up to 12 months.
  • Inability to take FAF imaging due to neck stiffness or other medical issue.
  • Inability to maintain post operation head positioning
  • Mental incapacity
  • Inability to sign on informed consent.
  • Patient is unwilling or unable to follow or comply with all study related procedures or to sign informed consent form

结局指标

主要结局

Retinal Displacement

时间窗: 3 (60 up to 120 days) months

The retinal displacement is assessed by the presence of retinal vessels printing (RVP) on Autofluorescence Imaging. FAF imaging will be assessed by 2 independent masked graders, who will indicate in retinal displacement is present or not. On those images that retinal displacement is noted, the distance between RVP and retinal vessels will be measured on the Optos system.

次要结局

  • Visual Acuity (ETDRS)(12 (10 up to 14 months) months)
  • Retinal Displacement(12 (10 up to 14 months) months)
  • Visual Distortion and Metamorphopsia (M-Chart)(3 (60 up to 120 days) and 12 (10 up to 14 months) months)
  • Aniseikonia test(3 (60 up to 120 days) and 12 (10 up to 14 months) months)
  • Foveal avascular zone (FAZ) area and findings in OCT angiography(3 (60 up to 120 days) and 12 (10 up to14 months) months)
  • Optical Coherence Tomography (OCT) changes(3 (60 up to 120 days) and 12 (10 cup to 14 months) months)
  • Metamorphopsia questionnaire(3 (60 up to 120 days) and 12 (10 up to14 months) months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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