GlaucomaPSOCTNCT01222065
Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis
An observational study of Glaucoma, run by Courtney Frazier Swaney at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 45 normal volunteers and 40 glaucoma patients (known visual field defects)with equal sex distribution between the ages of 40 and 80 will be recruited for this study by H. Grady Rylander, M.D. at The Eye Institute of Austin and grouped by age into the following categories: 40-49, 50-59, 60-69, 70-79. Every effort will be made to equalize the number of patients in each age category and to recruit volunteers representing the race distribution in our community. Maps of RNFLT, phase retardation, and RNFL birefringence will be acquired from individuals within each age category.
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.
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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.
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Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Neurotubules, Birefringence, Retinal Nerve Fiber Layer (RNFL)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma/Normal | Two groups will be studies: patients with glaucomatous visual field loss and age and gender matched normal patients without visual field loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The time frame to assess the effectiveness of the diagnostic algorithm is 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startAug 2007
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Courtney Frazier Swaney
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor-investigator, Courtney Frazier Swaney, University of Texas at Austin
- Investigators
- Henry G Rylander, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222065
- Sponsor's protocol ID
- 2007-04-0101
- Other IDs
- R01EY016462
- Acronym
- PSOCT
- Status last verified
- Mar 2012
- First submitted
- 14 Oct 2010
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19654746Pocock 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.
PubMed 19494208Liu 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.
PubMed 20431701
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polarization Sensitive Retinal Tomography for Glaucoma Diagnosis
- ClinicalTrials.gov ID
- NCT01222065
- Acronym / sponsor ID
- PSOCT / 2007-04-0101
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Neurotubules, Birefringence, Retinal Nerve Fiber Layer (RNFL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Courtney Frazier SwaneyUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Aug 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma/Normal | – | –Two groups will be studies: patients with glaucomatous visual field loss and age and gender matched normal patients without visual field loss |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 45 normal volunteers and 40 glaucoma patients (known visual field defects)with equal sex distribution between the ages of 40 and 80 will be recruited for this study by H. Grady Rylander, M.D. at The Eye Institute of Austin and grouped by age into the following categories: 40-49, 50-59, 60-69, 70-79. Every effort will be made to equalize the number of patients in each age category and to recruit volunteers representing the race distribution in our community. Maps of RNFLT, phase retardation, and RNFL birefringence will be acquired from individuals within each age category.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity/specificity of PSOCT to classify glaucoma vs. non-glaucoma
Time frame: The time frame to assess the effectiveness of the diagnostic algorithm is 1 year
Features from RNFL phase retardation and birefringence maps will be combined into a diagnostic algorithm to differentiate glaucoma vs. non-glaucoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Results publication: PubMed 19654746Park 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.
- Results publication: PubMed 19494208Pocock 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.
- Results publication: PubMed 20431701Liu 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.
- BME website with links to facultyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry G Rylander, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Courtney Frazier Swaney at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity/specificity of PSOCT to classify glaucoma vs. non-glaucoma (time frame: The time frame to assess the effectiveness of the diagnostic algorithm is 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01222065, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.