Utility of Heidelberg Retina Tomograph in Monitoring Glaucoma Progression
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|ClinicalTrials.gov Identifier: NCT00424996|
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : May 21, 2014
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).
|Condition or disease|
|Glaucoma Ocular Hypertension|
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 Type :||Observational|
|Actual Enrollment :||74 participants|
|Official Title:||Utility of Heidelberg Retina Tomograph in Monitoring Glaucoma Progression|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424996
|University of Toronto; Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Yvonne Buys, MD, FRCSC||University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada|
|Study Director:||Graham E Trope, PhD, FRCSC||University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada|
|Study Chair:||John Flanagan, PhD||University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada|