Clinical Trials Directory

Trials / Completed

CompletedNCT02526654

Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
115 (actual)
Sponsor
Wills Eye · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTHeidelberg Edge PerimeterHEP measures peripheral vision
DIAGNOSTIC_TESTOctopus Visual FieldOVF measures peripheral vision
DIAGNOSTIC_TESTOptical Coherence TomographyOCT measures retinal nerve fiber layer thickness

Timeline

Start date
2014-12-01
Primary completion
2015-06-01
Completion
2015-07-01
First posted
2015-08-18
Last updated
2019-09-16
Results posted
2019-09-16

Source: ClinicalTrials.gov record NCT02526654. Inclusion in this directory is not an endorsement.