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Completed

NCT Number: NCT02526654

Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heidelberg Edge Perimeter

Diagnostic Test

HEP measures peripheral vision

Other names: HEP

Octopus Visual Field

Diagnostic Test

OVF measures peripheral vision

Other names: OVF

Optical coherence tomography

Diagnostic Test

OCT measures retinal nerve fiber layer thickness

Other names: OCT

Primary outcomes

  1. Correlation Coefficient Between HEP and OVF Mean Deviation (MD)

    Time frame: 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.

Secondary outcomes

  1. Repeatability of Optical Coherence Tomography (OCT) Parameters

    Time frame: Month 6 visit, 1 hour

    A subgroup of participants were randomly selected to return at 3 and 6 months for repeat testing. Not all eyes were included. Repeatability of optical coherence tomography (OCT) to consistently detect minimum rim width (MRW) global thickness will be assessed by Pearson's interclass correlation coefficients (ICC). A larger ICC indicates measurements have greater repeatability. Greater than 0.75 indicated excellent repeatability; 0.40 to 0.75 indicated fair to good, and less than 0.40 indicated poor reliability.

  2. Correlations Between Structure-function Automated Report and Clinical Impression

    Time frame: Baseline visit, 1 hour

    Heidelberg Edge Perimeter (HEP) Visual Field (VF) and spectral domain optical coherence tomography (SD OCT) printouts from only the glaucoma subgroup were assessed. Retinal Nerve Fiber Layer (RNFL) and Minimum Rim Width (MRW) from SD OCT and HEP VF automated reports were compared to the clinical interpretations by 3 glaucoma specialists.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

Validation and Reproducibility of the Heidelberg Edge Perimeter in the Detection of Visual Field Defects in Glaucomatous Patients

Acronym: HEP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2015
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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