Clinical trial NCT02622191: Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye
Official title: Segmental Analysis of Retinal Layers and Measurement of Lamina Cribrosa Thickness in Patients With Asymmetric Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Optical Coherence Tomography
Primary Open Angle Glaucoma
Visual Field
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements
timeFrame: 1 examination, approximately one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wills Eye Hospital
name: L J Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.