Glaucoma
Conditions
Keywords
Glaucoma, Optical Coherence Tomography, Primary Open Angle Glaucoma, Visual Field
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.
Interventions
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).
Sponsors
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements | 1 examination, approximately one hour | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 14 |
| Total | 33 |
Baseline characteristics
| Characteristic | Open-angle Glaucoma | Healthy Controls | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 10 Participants | 23 Participants |
| Region of Enrollment United States | 19 participants | 14 participants | 33 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 14 |
| other Total, other adverse events | 0 / 19 | 0 / 14 |
| serious Total, serious adverse events | 0 / 19 | 0 / 14 |
Outcome results
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.
Time frame: 1 examination, approximately one hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Open-angle Glaucoma Affected Eye | Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements | 264.3 micro-ohms |
| Healthy Controls | Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements | 273.3 micro-ohms |
| Open-angle Glaucoma Fellow Eye | Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements | 276.2 micro-ohms |