Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis

NCT ID: NCT01222065

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-03-31

Brief Summary

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The proposed human clinical studies have three main objectives:

1. To determine reproducibility of peripapillary birefringence maps and identify features that measure the health of the RNFL.
2. To determine the normal variation in the birefringence maps with age.
3. To develop and test a classifier for glaucoma based on the birefringence maps using a case-control clinical trial.

This study is a case-control study intended to optimize feature selection for a future multi-center blinded study. The proposed clinical study does not measure conversion from normal to glaucoma.

Detailed Description

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This study evaluates RNFL Birefringence in normal and glaucoma human subjects: The primate experimental glaucoma study will characterize the spatial and temporal dynamics of RNFL birefringence during glaucoma progression and establish an initial feature set and classifier for a case-control clinical study. The case-control clinical study will refine the initial feature set and classifier and use ROC analysis to test sensitivity and specificity of the feature set and classifier for discriminating between normal and glaucomatous human eyes. The feature set and classifier formulated in the case-control clinical study is a prerequisite for planning a large-scale longitudinal study. A large-scale longitudinal study to compare different approaches for detecting early glaucoma is outside the scope of the proposed research. Moreover, considering the large number of subjects required for statistical significance when the conversion rate from ocular hypertensive to glaucoma is low (\<10%/year), a longitudinal study is best performed in a multi-institution clinical trial over several years.

Conditions

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Glaucoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Glaucoma/Normal

Two groups will be studies: patients with glaucomatous visual field loss and age and gender matched normal patients without visual field loss

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Courtney Frazier Swaney

OTHER

Sponsor Role lead

Responsible Party

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Courtney Frazier Swaney

Office of Sponsored Projects

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henry G Rylander, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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Eye Institute of Austin

Austin, Texas, United States

Site Status

Countries

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United States

References

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Park J, Kemp NJ, Rylander HG 3rd, Milner TE. Complex polarization ratio to determine polarization properties of anisotropic tissue using polarization-sensitive optical coherence tomography. Opt Express. 2009 Aug 3;17(16):13402-17. doi: 10.1364/oe.17.013402.

Reference Type RESULT
PMID: 19654746 (View on PubMed)

Pocock GM, Aranibar RG, Kemp NJ, Specht CS, Markey MK, Rylander HG 3rd. The relationship between retinal ganglion cell axon constituents and retinal nerve fiber layer birefringence in the primate. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5238-46. doi: 10.1167/iovs.08-3263. Epub 2009 Jun 3.

Reference Type RESULT
PMID: 19494208 (View on PubMed)

Liu S, Paranjape AS, Elmaanaoui B, Dewelle J, Rylander HG 3rd, Markey MK, Milner TE. Quality assessment for spectral domain optical coherence tomography (OCT) images. Proc SPIE Int Soc Opt Eng. 2009;7171:71710X. doi: 10.1117/12.809404.

Reference Type RESULT
PMID: 20431701 (View on PubMed)

Related Links

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http://www.bme.utexas.edu

BME website with links to faculty

Other Identifiers

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R01EY016462

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007-04-0101

Identifier Type: -

Identifier Source: org_study_id

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