Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424996
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2007-01-19
Brief Title:
Utility of Heidelberg Retina Tomograph in Monitoring Glaucoma Progression
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Utility of Heidelberg Retina Tomograph in Monitoring Glaucoma Progression
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 55 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 262 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 478 while the negative predictive value was 903
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 522 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 andor 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 andor visual field changes in patients with OHT and glaucoma
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 55 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 262 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 478 while the negative predictive value was 903
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 522 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 andor 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 andor visual field changes in patients with OHT and glaucoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None