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临床试验/CTRI/2019/11/022048
CTRI/2019/11/022048尚未招募未知

Comparison of macular thickness, ganglion cell analysis (GCA), retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) measurements of PRIMUS 300 and CIRRUS HD-OCT, Model 5000

Carl Zeiss India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方

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

入选标准

  • For inclusion, as normal subject, both eyes (OD & OS) must fulfill all of the following
  • 1.Males or females 18 years of age or older
  • 2. No history and evidence of retinal pathology or glaucoma
  • Retinal disease subjects (any eye OD or OS must meet any of the
  • 1.Males or females 50 years of age or older with diagnosis of active or recurrent neovascular age-related macular degeneration with presence of either drusen, pigment epithelial detachment or choroidal neovascularisation
  • 2.Males or females 18 years of age or older with diagnosis of persistent diabetic macular
  • edema or cystoid macular edema or proliferative diabetic retinopathy
  • 3.Males or females 18 years of age or older, with diagnosis of macular hole or vitreomacular
  • 4. Males or females 18 years of age or older with diagnosis of either sub-retinal fluid
  • (neurosensory detachment), subretinal hemorrhage, intraretinal atrophy, RPE disruption and tear, lamellar holes, exudates, fibrotic disciform scar, ischemic tissue, intra-retinal hemorrhage, vitreous hemorrhage, vascular occlusive disease, central serous retinopathy, epiretinal membranes, or other retinal disease
  • Glaucoma Subjects (any eye, OD or OS)
  • 1.Males or females 18 years of age or older, with a diagnosis of glaucoma of any type,
  • ranging from early to advanced stage

排除标准

  • Exclusion criteria
  • 1. Best spectacle corrected visual acuity worse than 20/40 in either eye (normal subjects
  • 2.Inability to clinically view the optic discs due to media opacity or poorly dilating pupil
  • 3.Unable to understand and follow the instructions on study procedures
  • 4. Unable to cooperate for study procedures, specifically in terms of fixation
  • 5.Unable to sit upright in front of the device
  • 6.Presence of tremor, pathological rotational nystagmus and dyspnea
  • 7. Any active infection of anterior or posterior segments
  • 8.Unable to return for the required study visits

研究者

发起方
Carl Zeiss India Pvt Ltd

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