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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-angle glaucoma | Experimental | 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. |
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| Healthy Controls | Experimental | Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectral domain Optical Coherence Tomography | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 examination, approximately one hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| L J Katz, MD | Wills Eye Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26550975 | Result | 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. |
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Participants with unilateral primary open-angle glaucoma (POAG) were recruited from the Glaucoma Service at Wills Eye Hospital, Philadelphia, PA, USA. Healthy controls were recruited from staff, friends and family. All participants were recruited between November 2012 and February 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-angle Glaucoma | 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. Spectral domain Optical Coherence Tomography (SD-OCT): 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). |
| FG001 | Healthy Controls | Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control. Spectral domain Optical Coherence Tomography (SD-OCT): 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-angle Glaucoma | 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. Spectral domain Optical Coherence Tomography: Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | micro-ohms | 1 examination, approximately one hour |
|
1 examination, approximately one hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-angle Glaucoma | Participants with unilateral primary open-angle glaucoma (POAG) and visual field defect in only one eye. |
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Manual segmentation of macular layers, somewhat subjective measure, prone to errors of interpretation.
Cross sectional design did not allow for longitudinal tracking of fellow eyes. Pilot study was restricted by small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. L. Jay Katz | Wills Eye Hospital, Glaucoma Research Center | 215-928-3123 | ljkatz@willseye.org |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| BG001 | Healthy Controls | Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control. Spectral domain Optical Coherence Tomography: Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Open-angle Glaucoma Fellow Eye |
Fellow eye of patients with primary open-angle glaucoma and no visual field defect. |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Healthy Controls | Participants without glaucoma and no other eye diseases. | 0 | 14 | 0 | 14 | 0 | 14 |
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