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临床试验/NCT03978546
NCT03978546已完成不适用

Diagnostic Performance of Smart Supra Perimetry (SSP) in Comparison With Standard Automated Perimetry (SAP) and Ocular Coherence Tomography (OCT).

Manchester University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Diagnostic performance of smart supra perimetry

研究概览

简要总结

Early glaucomatous visual field changes can be missed with the routinely used Standard Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10 degrees. While this shortcoming can be overcome with the addition of a 10-2 test, performing both tests places extra demand on the perimetric services (doubling test times) and patients.

Smart Supra Perimetry (SSP) uses a new faster algorithm that can complete both 24-2 and 10-2 test patterns in a similar time frame to a single 24-2 SAP test. This comparative study aims to determine the sensitivity and specificity (i.e. diagnostic accuracy) of SSP in identifying early glaucomatous visual field loss. A sample of 100 patients with early/suspect glaucoma will undergo SAP 24-2 and 10-2 (SITA algorithm) using Humphrey visual field perimetry and SSP 24+10-2 using Henson 9000. Eyes will be categorised into 2 groups i.e., glaucoma and non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician. The sensitivity and specificity of the SAP and SSP tests will be established along with test duration. The size and location of defects established with both the SAP and SSP strategies will also be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Reliable SAP visual field results (fixation loss < 33%, false positive < 15% and false negative < 20%).
  • •Visual acuity better or equal to 0.20 logMAR.
  • •Spherical refractive error within -6.00 to +6.00D and cylindrical error <2.00D
  • •No ocular co-morbidity likely to affect the visual field or OCT results.
  • •Age: 40-80 yrs
  • •Additional inclusion criteria for glaucomatous group:
  • •Optic disc showing glaucomatous changes.
  • •SAP MD not worse than -6dB
  • •Additional inclusion criteria non-glaucoma group:
  • •Normal SAP visual field data (MD, PSD, GHT within normal range)
  • •No evidence of glaucoma or other Ocular co-morbidity in the eye suitable for the study.

排除标准

  • •Exclusion criteria glaucomatous and control groups:
  • •Anomalous discs, Tilted discs, myopic discs.

研究组 & 干预措施

Non-Glaucoma Patient Arm

Experimental

All participants will complete the same assessments

干预措施: Humphrey Visual Field Test (Diagnostic Test)

Non-Glaucoma Patient Arm

Experimental

All participants will complete the same assessments

干预措施: Optical Coherence Tomography (OCT) Scan (Diagnostic Test)

Non-Glaucoma Patient Arm

Experimental

All participants will complete the same assessments

干预措施: Smart Perimetry - Henson 9000 (Diagnostic Test)

Glaucoma Patient Arm

Experimental

All participants will complete the same assessments

干预措施: Humphrey Visual Field Test (Diagnostic Test)

Glaucoma Patient Arm

Experimental

All participants will complete the same assessments

干预措施: Optical Coherence Tomography (OCT) Scan (Diagnostic Test)

Glaucoma Patient Arm

Experimental

All participants will complete the same assessments

干预措施: Smart Perimetry - Henson 9000 (Diagnostic Test)

结局指标

主要结局

Diagnostic performance of smart supra perimetry

时间窗: 12 months

Area under the curve for Smart Suprathrold Perimetry using probability thresholds to differentiate early glaucoma from non-glaucomatous visual fields.

次要结局

  • Diagnostic performance of Optical Coherent Tomography(12 months)
  • Diagnostic performance of Standard Automated perimetry(12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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