Utility of Heidelberg Retina Tomograph in Monitoring Glaucoma Progression

NCT00424996 | Completed

• 1 other identifier: UHNToronto
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  8 year study

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University glaucoma unit

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Glaucoma Research Society of Canada: collaborator

Study Sites (1)

University of Toronto; Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• 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.

  PMID: 17361246 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Yvonne Buys, MD, FRCSC

  University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

• Graham E Trope, PhD, FRCSC

  University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada

  STUDY DIRECTOR

• John Flanagan, PhD

  University of Toronto, Department of Ophthalmology; Toronto Western Hospital, Toronto, Ontario, Canada

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 22, 2007
• Study Start: August 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

CA (1)