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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- To evaluate the equivalence of the means of 26 measurement parameters: macular thickness (9 parameters), ganglion cell analysis (7 parameters), RNFL thickness (5 parameters), ONH measurements (5 parameters), between PRIMUS 300 and CIRRUS 5000 for the purpose of reusing CIRRUS reference database
研究概览
简要总结
OBJECTIVES:
-
To evaluate the equivalence of the means of 26 measurement parameters: macular thickness (9 parameters), ganglion cell analysis (7 parameters), RNFL thickness (5 parameters), ONH measurements (5 parameters), between PRIMUS 300 and CIRRUS 5000 for the purpose of reusing CIRRUS reference database
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To determine the repeatability and reproducibility of PRIMUS 300 macular thickness, ganglion cell analysis, RNFL thickness & ONH measurements
Study Design & Overview
This is a prospective single centre, comparative study and will undergo approval process by study independent ethics committee, prior to study initiation.
Informed consent will be obtained after explaining the nature and purpose of study. Any further study related procedures will be undertaken after obtaining informed consent from the subjects.
The study will include a total of 165 eligible subjects. Both normal subjects & subjects with ocular disease will be enrolled in this study. A previous diagnosis of retinal disease or glaucoma will be noted as part of the study procedures. Subjects may undergo the study site’s standard practice of clinical and eye examination procedures on the same date as their study visit, but is not a requirement. The subjects will be evaluated for eligibility and study enrollment within 3 study groups, normal, retinal disease & glaucoma.
For a subject with no known retinal disease or glaucoma, both the eyes (OD & OS) will be scanned. The assignment of scan type for the eyes (OD/OS), either macular cube scans or RNFL/ONH scans and acquisitions on the study devices will be as per the randomization table. For a subject with known retinal disease, the study eye (OD/OS) will be assigned by the Investigator based on the disease findings and macular cube scans will be acquired only on the study eye. Scan acquisitions using the study devices will be as per the randomization table. For a subject with known glaucoma, the study eye (OD/OS) will be assigned by the Investigator based on the disease findings and GCA & RNFL/ONH scans will be acquired only on the study eye. Scan acquisitions using the study devices will be as per the randomization table.
Data collected in the study will be used to evaluate the equivalence of the means of 26 measurements, for the purpose of reusing the CIRRUS reference database. Three (3) PRIMUS 300 devices, one (1) CIRRUS 400 device and three (3) OCT operators with varied expertise will be involved in the study. All study activities will be performed in a single visit but scanning may be performed on an optional 2nd visit if necessary.
All the enrolled subjects with retinal disease and glaucoma will be managed for the condition as per the study site’s standard practice. The specific study procedures will have no influence on the decision making and disease management process practiced at the site.
Target population
Normal male and female subjects and subjects with known retinal disease and glaucoma of any type ranging from early to advanced stage, aged ≥ 18 years.
Statistical Methods
Agreement Analyses: For each macular thickness, ganglion cell analysis and RNFL/ONH parameter, the mean across different devices and operators will be calculated for the first measurement from each study eye for PRIMUS 300 and CIRRUS 5000
Transferring CIRRUS 5000 Reference Database: After comparing individual study eye groups for agreement, the normal eye group and retinal disease eye group will undergo a combined regression analysis to determine the appropriate conversion of CIRRUS 5000 reference data to apply to PRIMUS 300 data for macular thickness measurements. The normal eye group and glaucoma eye group will undergo a combined regression analysis to determine the appropriate conversion of CIRRUS 5000 reference data to apply to PRIMUS 300 data for MTA, GCA, RNFL and ONH measurements.
Repeatability and Reproducibility: An analysis of variance (ANOVA) model will be used to estimate the repeatability and
reproducibility of the parameters for PRIMUS 300.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •For inclusion, as normal subject, both eyes (OD & OS) must fulfill all of the following criteria 1.Males or females 18 years of age or older
- •No history and evidence of retinal pathology or glaucoma Inclusion criteria: 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 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 traction
- •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 Inclusion criteria: 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
- •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
- •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
- •Any active infection of anterior or posterior segments 8.Unable to return for the required study visits.
结局指标
主要结局
To evaluate the equivalence of the means of 26 measurement parameters: macular thickness (9 parameters), ganglion cell analysis (7 parameters), RNFL thickness (5 parameters), ONH measurements (5 parameters), between PRIMUS 300 and CIRRUS 5000 for the purpose of reusing CIRRUS reference database
时间窗: 4 Months
次要结局
- To determine the repeatability and reproducibility of PRIMUS 300 macular thickness,(ganglion cell analysis, RNFL thickness & ONH measurements)