Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spectral domain Optical Coherence Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Optical Coherence Tomography, Primary Open Angle Glaucoma, Visual Field
Eligibility Criteria
Inclusion Criteria:
- Best-corrected visual acuity of 20/40 or better
- No media opacities
- Spherical equivalent refractive errors in a range of -6 to +6 diopters
- Cylinder correction within 3.0 diopters.
Exclusion Criteria:
- Age < 18 years old
- Visual Acuity < 20/40
- Nuclear sclerosis > +2
- Corneal diseases
- Contact lens use
- History of posterior segment intraocular surgery
- Systemic or ocular diseases that can cause visual field loss.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Open-angle glaucoma
Healthy Controls
Arm Description
Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient.
Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.
Outcomes
Primary Outcome Measures
Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements
Using Spectral Domain optical coherence tomography (SD-OCT), horizontal macular thickness of the lamina cribrosa (boundaries of the retinal layers) is measured in the eyes of each participant in microohms.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02622191
Brief Title
Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye
Official Title
Segmental Analysis of Retinal Layers and Measurement of Lamina Cribrosa Thickness in Patients With Asymmetric Primary Open-Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to further understand glaucoma pathogenesis and progression by utilizing enhanced depth imaging optical coherence tomography to visualize and measure lamina cribrosa in vivo and segmentation technology to accurately delineate and measure boundaries of the retinal layers. Investigators will elaborate further on key concepts of lamina cribrosa thickness and trans-synaptic degeneration.
Detailed Description
Two important areas of the eye that need investigation in order to further understanding of glaucoma. First is the retina (part of the eye that converts images from the eye's optical system into electrical impulses sent along the optic nerve to the brain). Newer technology, Spectral Domain Optical Coherence Tomography (SD-OCT), allows us to look at different layers of the retina and carefully measure thickness of each layer. Second area is lamina cribrosa (a portion of the white part of the eye which has nerve fibers passing through it connecting the eye to the brain). If lamina cribrosa is thin, it is possible it may bend easily and disrupt nerve fibers. SD-OCT allows measurement of lamina cribrosa thickness.
Findings will help monitor changes that occur in the eye as a result of glaucoma.
Individuals with primary open-angle glaucoma and unilateral visual field defects were chosen as the main patient population (in addition to normal controls). By approximating each participants baseline anatomy using the fellow, "internal control" eye, investigators will be able to better determine if any changes occur in the macula or the lamina cribrosa as a result of glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Optical Coherence Tomography, Primary Open Angle Glaucoma, Visual Field
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-angle glaucoma
Arm Type
Experimental
Arm Description
Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient.
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.
Intervention Type
Device
Intervention Name(s)
Spectral domain Optical Coherence Tomography
Other Intervention Name(s)
SD-OCT
Intervention Description
Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea were acquired using Spectralis Heidelberg Retinal Angiography (HRA)+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany).
Primary Outcome Measure Information:
Title
Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements
Description
Using Spectral Domain optical coherence tomography (SD-OCT), horizontal macular thickness of the lamina cribrosa (boundaries of the retinal layers) is measured in the eyes of each participant in microohms.
Time Frame
1 examination, approximately one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Best-corrected visual acuity of 20/40 or better
No media opacities
Spherical equivalent refractive errors in a range of -6 to +6 diopters
Cylinder correction within 3.0 diopters.
Exclusion Criteria:
Age < 18 years old
Visual Acuity < 20/40
Nuclear sclerosis > +2
Corneal diseases
Contact lens use
History of posterior segment intraocular surgery
Systemic or ocular diseases that can cause visual field loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L J Katz, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26550975
Citation
Zangalli CS, Ahmed OM, Waisbourd M, H Ali M, Cvintal V, Affel E, Gupta L, Katz LJ, C Sergott R. Segmental Analysis of Macular Layers in Patients With Unilateral Primary Open-Angle Glaucoma. J Glaucoma. 2016 Apr;25(4):e401-7. doi: 10.1097/IJG.0000000000000336.
Results Reference
result
Learn more about this trial
Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye
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