Open Angle GlaucomaNCT00430287
Does the Optic Disc Grading Done Visually by Your Doctor Agree With Optic Nerve Testing Which is Done by Machines?
An observational study of Open Angle Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT (Heidelberg Retinal Tomography) and the HVF (Humphrey… Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: glaucoma service
Who may be able to join
- Vision 20/50 or better
- Less than 3 diopters of astigmatism
- 3 diopters or less of myopia or hyperopia
- Pattern Standard Deviation on HVF less than 2.5dB in normals
- Pattern Standard Deviation on HVF greater than 2.5 db in glaucoma patients
Who cannot join
- Abnormalities of cornea or ocular media
- Significant ocular pathologies affecting visual field
- History of hypotony
- Ocular surgery within 6 months
- Nystagmus
- Unreliable visual fields
- OCT signal strength scan less than 6
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
Official title: Correlation of DDLS Grading to OCT, HRT, and HVF
The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).
Read the detailed description
The Disc Damage Likelihood Scale (DDLS) has been shown to be a reproducible method for clinicians to evaluate the optic nerve for glaucomatous damage and is highly correlated to diagnosis of glaucoma, severity of glaucoma as evidenced by visual field loss and Heidelberg Retina Tomography (HRT) evaluation. In comparison with the commonly used cup-disc ratio, the DDLS has less inter-observer variation and captures glaucomatous aspects of the optic nerve not assessed by the cup-disc ratio. The optic nerve imagers do not have the potential to completely replace the clinical examination of the optic nerve since they do not assess many critical features such as optic nerve pallor, hemorrhages, asymmetry of disc size, edema, etc. The DDLS presents the opportunity to provide a system to clinicians to increase the quality and objectivity of clinical optic nerve evaluation. The purpose of this study is to investigate the correlation of the DDLS grading to OCT, HRT and HVF testing of glaucomatous and normal optic nerves.
- Conditions
- Open Angle Glaucoma
- Keywords
- primary open angle glaucoma, low tension glaucoma, pigmentary glaucoma, exfoliative glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1: Primary open angle glaucoma | Patients with a form of primary open angle glaucoma | |
| 2: No known eye disease (controls) | Patients with no known eye disease (controls) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Jonathon Myers, Wills Eye
- Investigators
- Jonathan S Myers, MD, Principal investigator, Wills Eye Glaucoma Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430287
- Sponsor's protocol ID
- 06-775
- Status last verified
- Nov 2016
- First submitted
- 30 Jan 2007
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript has been published.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of DDLS Grading to OCT, HRT, and HVF
- ClinicalTrials.gov ID
- NCT00430287
- Acronym / sponsor ID
- 06-775
- Conditions
- Open Angle Glaucoma
- Keywords
- primary open angle glaucoma, low tension glaucoma, pigmentary glaucoma, exfoliative glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).
Detailed description
The Disc Damage Likelihood Scale (DDLS) has been shown to be a reproducible method for clinicians to evaluate the optic nerve for glaucomatous damage and is highly correlated to diagnosis of glaucoma, severity of glaucoma as evidenced by visual field loss and Heidelberg Retina Tomography (HRT) evaluation. In comparison with the commonly used cup-disc ratio, the DDLS has less inter-observer variation and captures glaucomatous aspects of the optic nerve not assessed by the cup-disc ratio. The optic nerve imagers do not have the potential to completely replace the clinical examination of the optic nerve since they do not assess many critical features such as optic nerve pallor, hemorrhages, asymmetry of disc size, edema, etc. The DDLS presents the opportunity to provide a system to clinicians to increase the quality and objectivity of clinical optic nerve evaluation. The purpose of this study is to investigate the correlation of the DDLS grading to OCT, HRT and HVF testing of glaucomatous and normal optic nerves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Primary open angle glaucoma | – | –Patients with a form of primary open angle glaucoma |
| 2: No known eye disease (controls) | – | –Patients with no known eye disease (controls) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma service
Key inclusion criteria (5 listed)
- Vision 20/50 or better
- Less than 3 diopters of astigmatism
- 3 diopters or less of myopia or hyperopia
- Pattern Standard Deviation on HVF less than 2.5dB in normals
- Pattern Standard Deviation on HVF greater than 2.5 db in glaucoma patients
Key exclusion criteria (7 listed)
- Abnormalities of cornea or ocular media
- Significant ocular pathologies affecting visual field
- History of hypotony
- Ocular surgery within 6 months
- Nystagmus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Individual participant dataSharing planned: Yes. A manuscript has been published.
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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.
Jonathan S Myers, MD principal investigator
Wills Eye Glaucoma Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by Wills Eye at 1 site in United States.
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 7 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 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 10 Nov 2016; AzTrials last refreshed its copy on 27 Oct 2026.