Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye
Segmental Analysis of Retinal Layers and Measurement of Lamina Cribrosa Thickness in Patients With Asymmetric Primary Open-Angle Glaucoma
1 other identifier
interventional
33
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
December 4, 2015
CompletedResults Posted
Study results publicly available
February 27, 2019
CompletedMarch 15, 2019
February 1, 2019
3 months
November 17, 2015
December 13, 2017
February 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Open-angle glaucoma
EXPERIMENTALParticipants 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.
Healthy Controls
EXPERIMENTALParticipants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wills Eyelead
Related Publications (1)
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.
PMID: 26550975RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. L. Jay Katz
- Organization
- Wills Eye Hospital, Glaucoma Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
L J Katz, MD
Wills Eye Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 17, 2015
First Posted
December 4, 2015
Study Start
November 1, 2012
Primary Completion
February 1, 2013
Study Completion
December 1, 2013
Last Updated
March 15, 2019
Results First Posted
February 27, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share