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OpenTrials
Completed

NCT Number: NCT02622191

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: SD-OCT

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

Segmental Analysis of Retinal Layers and Measurement of Lamina Cribrosa Thickness in Patients With Asymmetric Primary Open-Angle Glaucoma

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2015
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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