Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects

NCT02526654 | Completed Results

• 1 other identifier: 13-340
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Glaucoma Subjects

EXPERIMENTAL

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; Diagnostic Test: Octopus Visual Field; Diagnostic Test: Optical Coherence Tomography

Healthy Controls

EXPERIMENTAL

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; Diagnostic Test: Octopus Visual Field; Diagnostic Test: Optical Coherence Tomography

Interventions

Heidelberg Edge Perimeter DIAGNOSTIC_TEST

HEP measures peripheral vision

Also known as: HEP

Glaucoma Subjects; Healthy Controls

Octopus Visual Field DIAGNOSTIC_TEST

OVF measures peripheral vision

Also known as: OVF

Glaucoma Subjects; Healthy Controls

Optical Coherence Tomography DIAGNOSTIC_TEST

OCT measures retinal nerve fiber layer thickness

Also known as: OCT

Glaucoma Subjects; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wills Eye: lead

Related Publications (1)

• 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.

  PMID: 29396688 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Limitations and Caveats

Small sample size and varied severity of disease in the glaucoma group.

Results Point of Contact

• Title: Dr. L. Jay Katz
• Organization: Wills Eye Hospital, Glaucoma Research Center

ljkatz@willseye.org

215-928-3123

Study Officials

• Leslie J Katz, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 18, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share