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

NCT ID: NCT02622191

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Open-angle glaucoma

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.

Group Type: EXPERIMENTAL

Spectral domain Optical Coherence Tomography

Intervention Type: 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).

Healthy Controls

Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control.

Group Type: EXPERIMENTAL

Spectral domain Optical Coherence Tomography

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

SD-OCT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wills Eye

OTHER

Sponsor Role: lead

Responsible Party

L. Jay Katz MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

L J Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Hospital

References

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.

Reference Type: RESULT

PMID: 26550975 (View on PubMed)

Other Identifiers

12-229

Identifier Type: -

Identifier Source: org_study_id