Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects (HEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Diagnostic test: Heidelberg Edge Perimeter; Diagnostic test: Octopus Visual Field; Diagnostic test: Optical Coherence Tomography

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Heidelberg Edge Perimeter; HEP measures peripheral vision; Other Names: HEP; Diagnostic test: Octopus Visual Field; OVF measures peripheral vision; Other Names: OVF; Diagnostic test: Optical Coherence Tomography; OCT measures retinal nerve fiber layer thickness; Other Names: OCT
Experimental: 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.	Diagnostic test: Heidelberg Edge Perimeter; HEP measures peripheral vision; Other Names: HEP; Diagnostic test: Octopus Visual Field; OVF measures peripheral vision; Other Names: OVF; Diagnostic test: Optical Coherence Tomography; OCT measures retinal nerve fiber layer thickness; Other Names: OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Coefficient Between HEP and OVF Mean Deviation (MD)	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.	Baseline visit, 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability of Optical Coherence Tomography (OCT) Parameters	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.	Month 6 visit, 1 hour
Correlations Between Structure-function Automated Report and Clinical Impression	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.	Baseline visit, 1 hour

Collaborators and Investigators

• Sponsor: Wills Eye
• Investigators: Principal Investigator: Leslie J Katz, MD, Wills Eye Hospital

Publications and helpful links

General Publications

• Cui QN, Fudemberg SJ, Resende AF, Vu TA, Zhou C, Rahmatnejad K, Hark LA, Myers JS, Katz LJ, Waisbourd M. Validation of the structure-function correlation report from the heidelberg edge perimeter and spectral-domain optical coherence tomography. Int Ophthalmol. 2019 Mar;39(3):533-540. doi: 10.1007/s10792-018-0836-z. Epub 2018 Feb 2.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 13-340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No