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Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye

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ClinicalTrials.gov Identifier: NCT02622191
Recruitment Status : Completed
First Posted : December 4, 2015
Results First Posted : February 27, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Spectral domain Optical Coherence Tomography Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Segmental Analysis of Retinal Layers and Measurement of Lamina Cribrosa Thickness in Patients With Asymmetric Primary Open-Angle Glaucoma
Actual Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: 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.
Device: Spectral domain Optical Coherence Tomography
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).
Other Name: SD-OCT

Experimental: Healthy Controls
Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.
Device: Spectral domain Optical Coherence Tomography
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).
Other Name: SD-OCT




Primary Outcome Measures :
  1. Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622191


Sponsors and Collaborators
Wills Eye
Investigators
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Principal Investigator: L J Katz, MD Wills Eye Hospital

Publications of Results:
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Responsible Party: L. Jay Katz MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT02622191     History of Changes
Other Study ID Numbers: 12-229
First Posted: December 4, 2015    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: March 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by L. Jay Katz MD, Wills Eye:
Glaucoma
Optical Coherence Tomography
Primary Open Angle Glaucoma
Visual Field

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases