Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects

Wills Eye

Status: Completed

Conditions: Glaucoma

Treatments: Diagnostic Test: Heidelberg Edge Perimeter; Diagnostic Test: Octopus Visual Field; Diagnostic Test: Optical Coherence Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02526654

13-340

Details and patient eligibility

About

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.

Full description

Each participant undergo the following tests:

1. 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).
2. Octopus Visual Field (OVF) Analyzer using G-top strategy recording mean deviation (MD) and pattern standard deviation (PSD).
3. Heidelberg Edge Perimeter (HEP) standard automated perimetry (SAP) using advanced staircase thresholding algorithm (ASTA).
4. 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Glaucoma Subjects

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Optical Coherence Tomography

Diagnostic Test: Octopus Visual Field

Diagnostic Test: Heidelberg Edge Perimeter

Healthy Controls

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Optical Coherence Tomography

Diagnostic Test: Octopus Visual Field

Diagnostic Test: Heidelberg Edge Perimeter