GlaucomaNCT00424996
Utility of Heidelberg Retina Tomograph in Monitoring Glaucoma Progression
An observational study of Glaucoma and Ocular Hypertension, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Glaucoma is a chronic disease defined by characteristic changes in the optic nerve associated initially with loss of peripheral vision and is treated by lowering intraocular (inside the eye) pressure. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2006to Dec 2013
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University glaucoma unit
Who may be able to join
- Best-corrected visual acuity of 20/40 or better
- Subjects determined to have OHT or glaucoma
- Spherical refraction within 6.0 D with plus or minus sphere, and cylinder within 3.0 D with plus or minus cylinder
- Subjects that show progression on the HRT
- subjects stable on ONH stereophotographs
- subjects with stable and reliable visual fields
- Subjects willing to make the required visits for the study
- Subjects tolerant to dilating drops
Who cannot join
- A suspicion or actual defect in the visual field of the eye being tested that is explained by the patient's ocular status or history, other than glaucoma
- Any history of disease or use of medication that may affect visual field reliability
- Past history of stroke or diabetic retinopathy
- Inability of the pupils to be dilated to at least 4 mm for the screening visit
- Inability to undergo either perimetry test or the ophthalmic examination
- Inability to undergo adequate or better quality stereophotographs
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto; Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Glaucoma is a chronic disease defined by characteristic changes in the optic nerve associated initially with loss of peripheral vision and is treated by lowering intraocular (inside the eye) pressure. It has been reported that noticeable changes to the optic nerve caused by glaucoma may occur several years before changes in vision are noticed. Since changes to the optic nerve and other eye structures due to glaucoma are irreversible, it is important to develop tools for the earliest possible detection of changes due to glaucoma.
The Heidelberg Retina Tomograph (HRT) is a device that is used to produce a three-dimensional map of the optic nerve and retina, and can be used to detect changes in the optic nerve and retina over time. In previous studies, it has been shown to be useful for the detection of changes due to glaucoma. However, the HRT when compared to other techniques to evaluate the optic nerve such as stereophotography, was found to only somewhat agree.
The current study will compare HRT to stereophotography to determine how good each one is at looking and documenting changes in the optic nerve over time due to glaucoma. Using HRT to initiate early topical medication or to change management requires knowing how well HRT results predict the development of visual loss. Accordingly, the results of this study may affect the management of glaucoma patients by optimizing the follow-up of people with this condition and by initiating appropriate and more individualized treatments. Early treatment is crucial for preventing further visual loss in patients with glaucoma or ocular hypertension (high pressure inside the eye).
Read the detailed description
In glaucoma, treatment decisions depend on the development of morphologic and functional damage. Therefore, damage serves as an indicator of management. Commonly, progression is determined by various perimetric techniques.
However, it has been reported that clinically detectable glaucomatous structural alteration of the ONH may precede the development of reproducible white on white and blue on yellow visual field defects by up to several years.
The HRT is a confocal scanning laser tomography device that creates a three-dimensional topographic analysis of the ONH and the peripapillary retina and includes a statistical analysis to evaluate structural change over time.
This technique showed good sensitivity and high specificity in detecting glaucoma progression when tested using computer simulation. The same good results were obtained by the same authors, in another study, in a small subgroup of 16 patients who were monitored for glaucomatous progression by both HRT and ONH stereophotographs for approximately 5.5 years.
However, in our recent retrospective study, our results demonstrated only fair agreement between HRT and clinical judgment of ONH stereophotographs for progression in glaucoma, for a mean follow-up time with HRT of 2.62 years. Although, the evaluation of the ONH stereophotographs is necessarily subjective, it is widely accepted and has been shown to be effective for evaluating change. Using the stereophotographs assessments as the "reference standard", the HRT sensitivity was 78% and the specificity to 70%. The positive predictive value of the HRT was 47.8%, while the negative predictive value was 90.3%.
According to the results of this study if the frequency of true positives and false positives does not change with longer follow-up, treatment decisions would be based on a test that may be in error 52.2% of the time.
Accordingly, our previous - and other studies - study demonstrated only fair agreement between HRT and clinical judgment of ONH stereophotographs for progression in glaucoma. At present, the available evidence does not appear to be sufficient to show that the addition of HRT improves the ability to predict the development of clinical optic disc change and/or visual field loss.
Therefore the aim of the current study is to investigate the clinical significance of the HRT in monitoring glaucoma progression. In other words we will investigate how well HRT results for glaucomatous progression are able to predict the future development of optic disc and/or visual field changes in patients with OHT and glaucoma.
- Conditions
- Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Ocular Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal tomography
Journal of OphthalmologyVolume 2014 (2014), Article ID 987389, 12 pageshttp://dx.doi.org/10.1155/2014/987389 Clinical Significance of Optic Disc Progression by Topographic Change Analysis Maps in Glaucoma: An 8-Year Follow-Up Study D. Kourkoutas,1 Y. M. Buys,2 J. G. Flanagan,2 N. Karamaounas,1 G. Georgopoulos,3 E. Iliakis,3 M. M. Moschos,3 and G. E. Trope2
Measured: 8 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Glaucoma Research Society of Canada
- Responsible party
- Principal investigator, Graham E Trope, University Health Network, Toronto
- Investigators
- Yvonne Buys, MD, FRCSC, Principal investigator, University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, CanadaGraham E Trope, PhD, FRCSC, Study director, University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, CanadaJohn Flanagan, PhD, Study chair, University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424996
- Sponsor's protocol ID
- UHNToronto
- Status last verified
- May 2014
- First submitted
- 19 Jan 2007
- Last updated
- 21 May 2014
- Results posted
- No
Publications
Kourkoutas D, Buys YM, Flanagan JG, Hatch WV, Balian C, Trope GE. Comparison of glaucoma progression evaluated with Heidelberg retina tomograph II versus optic nerve head stereophotographs. Can J Ophthalmol. 2007 Feb;42(1):82-8.
PubMed 17361246
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Heidelberg Retina Tomograph in Monitoring Glaucoma Progression
- ClinicalTrials.gov ID
- NCT00424996
- Acronym / sponsor ID
- UHNToronto
- Conditions
- Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Glaucoma Research Society of Canada
- Study start
- Aug 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jan 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.
Glaucoma is a chronic disease defined by characteristic changes in the optic nerve associated initially with loss of peripheral vision and is treated by lowering intraocular (inside the eye) pressure. It has been reported that noticeable changes to the optic nerve caused by glaucoma may occur several years before changes in vision are noticed. Since changes to the optic nerve and other eye structures due to glaucoma are irreversible, it is important to develop tools for the earliest possible detection of changes due to glaucoma.
The Heidelberg Retina Tomograph (HRT) is a device that is used to produce a three-dimensional map of the optic nerve and retina, and can be used to detect changes in the optic nerve and retina over time. In previous studies, it has been shown to be useful for the detection of changes due to glaucoma. However, the HRT when compared to other techniques to evaluate the optic nerve such as stereophotography, was found to only somewhat agree.
The current study will compare HRT to stereophotography to determine how good each one is at looking and documenting changes in the optic nerve over time due to glaucoma. Using HRT to initiate early topical medication or to change management requires knowing how well HRT results predict the development of visual loss. Accordingly, the results of this study may affect the management of glaucoma patients by optimizing the follow-up of people with this condition and by initiating appropriate and more individualized treatments. Early treatment is crucial for preventing further visual loss in patients with glaucoma or ocular hypertension (high pressure inside the eye).
Detailed description
In glaucoma, treatment decisions depend on the development of morphologic and functional damage. Therefore, damage serves as an indicator of management. Commonly, progression is determined by various perimetric techniques.
However, it has been reported that clinically detectable glaucomatous structural alteration of the ONH may precede the development of reproducible white on white and blue on yellow visual field defects by up to several years.
The HRT is a confocal scanning laser tomography device that creates a three-dimensional topographic analysis of the ONH and the peripapillary retina and includes a statistical analysis to evaluate structural change over time.
This technique showed good sensitivity and high specificity in detecting glaucoma progression when tested using computer simulation. The same good results were obtained by the same authors, in another study, in a small subgroup of 16 patients who were monitored for glaucomatous progression by both HRT and ONH stereophotographs for approximately 5.5 years.
However, in our recent retrospective study, our results demonstrated only fair agreement between HRT and clinical judgment of ONH stereophotographs for progression in glaucoma, for a mean follow-up time with HRT of 2.62 years. Although, the evaluation of the ONH stereophotographs is necessarily subjective, it is widely accepted and has been shown to be effective for evaluating change. Using the stereophotographs assessments as the "reference standard", the HRT sensitivity was 78% and the specificity to 70%. The positive predictive value of the HRT was 47.8%, while the negative predictive value was 90.3%.
According to the results of this study if the frequency of true positives and false positives does not change with longer follow-up, treatment decisions would be based on a test that may be in error 52.2% of the time.
Accordingly, our previous - and other studies - study demonstrated only fair agreement between HRT and clinical judgment of ONH stereophotographs for progression in glaucoma. At present, the available evidence does not appear to be sufficient to show that the addition of HRT improves the ability to predict the development of clinical optic disc change and/or visual field loss.
Therefore the aim of the current study is to investigate the clinical significance of the HRT in monitoring glaucoma progression. In other words we will investigate how well HRT results for glaucomatous progression are able to predict the future development of optic disc and/or visual field changes in patients with OHT and glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University glaucoma unit
Key inclusion criteria (8 listed)
- Best-corrected visual acuity of 20/40 or better
- Subjects determined to have OHT or glaucoma
- Spherical refraction within 6.0 D with plus or minus sphere, and cylinder within 3.0 D with plus or minus cylinder
- Subjects that show progression on the HRT
- subjects stable on ONH stereophotographs
Key exclusion criteria (6 listed)
- A suspicion or actual defect in the visual field of the eye being tested that is explained by the patient's ocular status or history, other than glaucoma
- Any history of disease or use of medication that may affect visual field reliability
- Past history of stroke or diabetic retinopathy
- Inability of the pupils to be dilated to at least 4 mm for the screening visit
- Inability to undergo either perimetry test or the ophthalmic examination
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
Retinal tomography
Time frame: 8 year study
Journal of OphthalmologyVolume 2014 (2014), Article ID 987389, 12 pageshttp://dx.doi.org/10.1155/2014/987389 Clinical Significance of Optic Disc Progression by Topographic Change Analysis Maps in Glaucoma: An 8-Year Follow-Up Study D. Kourkoutas,1 Y. M. Buys,2 J. G. Flanagan,2 N. Karamaounas,1 G. Georgopoulos,3 E. Iliakis,3 M. M. Moschos,3 and G. E. Trope2
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 21 May 2014.
- Background: PubMed 17361246Kourkoutas D, Buys YM, Flanagan JG, Hatch WV, Balian C, Trope GE. Comparison of glaucoma progression evaluated with Heidelberg retina tomograph II versus optic nerve head stereophotographs. Can J Ophthalmol. 2007 Feb;42(1):82-8.
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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.
Yvonne Buys, MD, FRCSC principal investigator
University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada
Graham E Trope, PhD, FRCSC study director
University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada
John Flanagan, PhD study chair
University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada
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 Glaucoma and Ocular Hypertension, run by University Health Network, Toronto at 1 site in Canada.
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 8 inclusion and 6 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 21 May 2014. 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 Canada. 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.
What does the primary outcome measure?
Retinal tomography (time frame: 8 year study). 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 NCT00424996, 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 21 May 2014.