GlaucomaHEPNCT02526654

Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects

A study testing Heidelberg Edge Perimeter, Octopus Visual Field and Optical Coherence Tomography in people with Glaucoma, run by Wills Eye.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Glaucoma
What is being tested?: Heidelberg Edge Perimeter, Octopus Visual Field and Optical Coherence Tomography
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: No sites listed yet
Study dates: Dec 2014to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

About this study

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

Read the detailed description

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.

Conditions: Glaucoma
Being tested: Heidelberg Edge Perimeter, Octopus Visual Field, Optical Coherence Tomography
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heidelberg Edge PerimeterDiagnostic test
Also called HEP
HEP measures peripheral vision
Octopus Visual FieldDiagnostic test
Also called OVF
OVF measures peripheral vision
Optical Coherence TomographyDiagnostic test
Also called OCT
OCT measures retinal nerve fiber layer thickness

Study groups in NCT02526654
Study group	Role	What they receive
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. Receives: 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. Receives: Diagnostic Test: Heidelberg Edge Perimeter; Diagnostic Test: Octopus Visual Field; Diagnostic Test: Optical Coherence Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline visit, 1 hour

Secondary outcomes (2)

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.
Measured: 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.
Measured: Baseline visit, 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Jul 2015

First posted18 Aug 2015 (estimated)
Study startDec 2014
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02526654
Sponsor's protocol ID: 13-340
Acronym: HEP
Status last verified: Aug 2019
First submitted: 30 Jul 2015
Last updated: 16 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 29396688

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation and Reproducibility of the Heidelberg Edge Perimeter in the Detection of Visual Field Defects in Glaucomatous Patients
ClinicalTrials.gov ID: NCT02526654
Acronym / sponsor ID: HEP / 13-340
Conditions: Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Wills EyeUniversity, hospital or other
Study start: Dec 2014 (actual)
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 18 Aug 2015 (estimated)
Results: Posted 16 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Glaucoma Subjects	Experimental	Diagnostic Test: Heidelberg Edge Perimeter, Diagnostic Test: Octopus Visual Field, Diagnostic Test: Optical Coherence TomographySubjects 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.
Healthy Controls	Experimental	Diagnostic Test: Heidelberg Edge Perimeter, Diagnostic Test: Octopus Visual Field, Diagnostic Test: Optical Coherence TomographySubjects 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Heidelberg Edge PerimeterAlso: HEPHEP measures peripheral vision	Diagnostic test	Glaucoma Subjects, Healthy Controls
Octopus Visual FieldAlso: OVFOVF measures peripheral vision	Diagnostic test	Glaucoma Subjects, Healthy Controls
Optical Coherence TomographyAlso: OCTOCT measures retinal nerve fiber layer thickness	Diagnostic test	Glaucoma Subjects, Healthy Controls

Primary outcome

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.

2 secondary outcomes

Repeatability of Optical Coherence Tomography (OCT) Parameters
Time frame: Month 6 visit, 1 hour
Correlations Between Structure-function Automated Report and Clinical Impression
Time frame: Baseline visit, 1 hour

Results and safety

Results posted to the registry on 16 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glaucoma Subjects	79	79
Healthy Controls	36	36

Primary outcome: Correlation Coefficient Between HEP and OVF Mean Deviation (MD)

Time frame: Baseline visit, 1 hour. Number. Unit: Pearson's correlation coefficient

Measure	Glaucoma Subjects n = 79	Healthy Controls n = 36
Value	-.86	-.37

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: eye examination, 1 hour. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glaucoma Subjects	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Healthy Controls	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Limitations and caveats (from the sponsor): Small sample size and varied severity of disease in the glaucoma group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29396688Cui 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.
Individual participant dataSharing planned: No

Related trials for Glaucoma

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie J Katz, MD principal investigator

Wills Eye Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Heidelberg Edge Perimeter, Octopus Visual Field and Optical Coherence Tomography in people with Glaucoma, run by Wills Eye.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation Coefficient Between HEP and OVF Mean Deviation (MD) (time frame: Baseline visit, 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.