Validation and Reproducibility of the Heidelberg Edge Perimeter in the Detection of Visual Field Defects in Glaucomatous Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 主要终点
- Correlation Coefficient Between HEP and OVF Mean Deviation (MD)
研究概览
简要总结
The purpose of this study is to compare standard automated perimetry (SAP) using the Heidelberg Edge Perimeter (HEP) to the Octopus Visual Field (OVF) analyzer and determine test-retest reliability of both parameters in detecting glaucomatous visual field losses. This study will also investigate novel imaging parameters of the optic nerve head and new automated structure-function reports.
详细描述
Each participant undergo the following tests:
- Standard ophthalmic examination (usual care): Best-corrected visual acuity, biomicroscopy (look at front of eye), intraocular pressure (IOP) using Goldman applanation tonometry, central corneal thickness measurement and fundoscopy (look at back of eye).
- Octopus Visual Field (OVF) Analyzer using G-top strategy recording mean deviation (MD) and pattern standard deviation (PSD).
- Heidelberg Edge Perimeter (HEP) standard automated perimetry (SAP) using advanced staircase thresholding algorithm (ASTA).
- Spectralis optical coherence tomography (OCT) using glaucoma module premium edition (GMPE) software to measure minimum rim width (MRW) and retinal nerve fiber layer (RNFL) thickness in 6 sectors (superior nasal, superior temporal, inferior nasal, inferior temporal, nasal and temporal) in the retina.
Order of HEP SAP III and OVF, and order of the eye tested (right vs. left) if both eyes of patients meet inclusion criteria will be randomized. Patients with glaucoma will be randomly chosen and asked to return in 3 to 6 months for repeat HEP and OVF testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years.
- •Best corrected visual acuity of 20/40 or better in the tested eye.
- •Spherical refraction within ±5.0 D, and cylinder correction within ±3.0 D.
- •History of glaucoma, defined as:
- •Characteristic of glaucomatous disc damage: (local narrowing, notching, or absence of the neuroretinal rim in the absence of disc pallor elsewhere).
排除标准
- •Any condition preventing adequate examination of the pupil or visual field testing (e.g. ptosis, dense corneal opacities or lens opacities);
- •Active infection of the anterior or posterior segments of the eye;
- •Any intraocular surgical or laser procedure within the previous 4 weeks;
- •Participants taking a medication known to affect visual field sensitivity, a coexisting intraocular disease affecting visual field, or a problem other than glaucoma affecting color vision will be excluded.
研究组 & 干预措施
Glaucoma Subjects
Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes. They will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
干预措施: Heidelberg Edge Perimeter (Diagnostic Test)
Glaucoma Subjects
Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes. They will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
干预措施: Octopus Visual Field (Diagnostic Test)
Glaucoma Subjects
Subjects with glaucoma were recruited based on characteristic glaucomatous disc damage and visual field changes. They will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
干预措施: Optical Coherence Tomography (Diagnostic Test)
Healthy Controls
Subjects that do not have glaucoma and are recruited for testing will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
干预措施: Heidelberg Edge Perimeter (Diagnostic Test)
Healthy Controls
Subjects that do not have glaucoma and are recruited for testing will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
干预措施: Octopus Visual Field (Diagnostic Test)
Healthy Controls
Subjects that do not have glaucoma and are recruited for testing will perform visual field with Heidelberg Edge Perimeter and Octopus visual field. Optical Coherence Tomography will image the retinal nerve fiber layer.
干预措施: Optical Coherence Tomography (Diagnostic Test)
结局指标
主要结局
Correlation Coefficient Between HEP and OVF Mean Deviation (MD)
时间窗: Baseline visit, 1 hour
Pearson's correlation coefficient between Heidelberg Edge Perimeter (HEP) and Octopus Visual Field (OVF) Mean Deviation (MD) for glaucoma patients and controls to determine if HEP can detect glaucoma as well as OVF. The closer the values of both parameters for both machines, the better comparable the two machines are to each other in detecting glaucoma.
次要结局
- Repeatability of Optical Coherence Tomography (OCT) Parameters(Month 6 visit, 1 hour)
- Correlations Between Structure-function Automated Report and Clinical Impression(Baseline visit, 1 hour)
研究者
L. Jay Katz MD
Principal investigator
Wills Eye