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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Spectral domain Optical Coherence Tomography

• Registration Number: NCT02622191
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-02
• Study Completion: 2013-12
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-04
• Results First Submitted: 2017-12-13
• Results First Submitted QC: 2018-10-18
• Status Verified: 2019-02
• Results First Posted: 2019-02-27
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Spectral domain Optical Coherence Tomography	Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.
Open-angle glaucoma	Spectral domain Optical Coherence Tomography	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.

Primary Outcome Measures

Name	Time	Method
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.