CTRI/2018/04/013512Other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 400
Carl Zeiss India Pvt Ltd0 个研究点目标入组 133 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- 入组人数
- 133
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 fulfil all of the following criteria
- •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 criteria)
- •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 neovascularization
- •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 Traction
- •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
- •1. Best spectacle corrected visual acuity worse than 20/40 in either eye (normal subjects only)
- •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
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