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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622191
• Other study ID #: 12-229
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2019
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

References & 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.0000000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 examination, approximately one hour