Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis

Study Overview
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Brief Summary
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The proposed human clinical studies have three main objectives: To determine reproducibility of peripapillary birefringence maps and identify features that measure the health of the RNFL. To determine the normal variation in the birefringence maps with age. 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.

Official Title
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Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis

Conditions
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Glaucoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient age between 40 and 80, visual acuity score of 20/40 or better; spherical refraction within ± 5 diopters, cylinder refraction within ± 3 diopters, ability to cooperate with study procedures and personnel and to perform tests reliably. Case-control assignment for the human clinical trials is based on medical and ocular history and on a comprehensive eye examination (including intraocular pressure history, standard disc photography and Humphrey-Zeiss 24-2 visual field test) by a glaucoma specialist. - Exclusion Criteria: discernable anomaly of the anterior chamber, uveitis, significant opacification of the cornea or crystalline lens, eyes with secondary glaucoma, eyes with pigmentary or pseudoexfoliation glaucoma, concurrent active eye disease in the study eye that may affect intraocular pressure or its measurement, patients on kidney dialysis, eyes with proliferative or severe nonproliferative retinopathy, retinal detachment, retinitis pigmentosa, or other significant retinopathy, eyes with field loss attributed to a non-glaucoma condition, dilated pupil diameter less than 4mm, and visual fields < 20 degrees. -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma/Normal<br>Two groups will be studies: patients with glaucomatous visual field loss and age and gender matched normal patients without visual field loss | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity/specificity of PSOCT to classify glaucoma vs. non-glaucoma | Features from RNFL phase retardation and birefringence maps will be combined into a diagnostic algorithm to differentiate glaucoma vs. non-glaucoma | The time frame to assess the effectiveness of the diagnostic algorithm is 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Neurotubules, Birefringence, Retinal Nerve Fiber Layer (RNFL)