Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis

Glaucoma Clinical Trial

— PSOCT  

Official title:

Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222065
• Other study ID #: 2007-04-0101
• Secondary ID: R01EY016462
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: March 26, 2012
• Start date: August 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
United States	Eye Institute of Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Courtney Frazier Swaney	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   BME website with links to faculty