N/A
N=115
Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02526654 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Correlation Coefficient Between HEP and OVF Mean Deviation (MD) — -.86; -.37 Pearson's correlation coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heidelberg Edge Perimeter (Diagnostic_test); Octopus Visual Field (Diagnostic_test); Optical Coherence Tomography (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Coefficient Between HEP and OVF Mean Deviation (MD) |
-.86; -.37 | — |
| SECONDARY Repeatability of Optical Coherence Tomography (OCT) Parameters |
.99; .99 | — |
| SECONDARY Correlations Between Structure-function Automated Report and Clinical Impression |
0.62 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02526654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.