Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-29 @ 10:02 PM
Study NCT ID:
NCT02600403
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2015-08-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure?
Sponsor:
Wills Eye
Organization:
Study Overview
Official Title:
Reversible Structural and Functional Changes After Intraocular Pressure Reduction in Patients With Glaucoma
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to evaluate structural and functional improvement after lowering intraocular pressure (IOP) in patients with glaucoma using Spectral Domain Optical Coherence Tomography (SD-OCT), Visual Field (VF) testing, and Visual Evoked Potential (VEP).
Detailed Description:
Glaucoma exhibits characteristic changes to the optic nerve in the back of the eye. The optic nerve is formed when fibers that overlay the retina come together. This layer is called the retinal nerve fiber layer (RNFL).
Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers in the retina and RNFL. This provides important anatomical information.
VEP (visual evoked potential) is an imaging system that measures electrical signals from the eye to the brain by using electrodes placed on the forehead and back of head. This is similar in principal to an electrocardiogram of the heart.
Visual field testing is done to evaluate the extent of side vision loss caused by various diseases of the eye, including glaucoma. This testing is performed as you stare at a small light directly in front of your eye while lights flash one at a time in every direction on a screen surrounding the central light. You push a button each time you see a flash out of the corner of your eye.
Lowering intraocular pressure (IOP) in the eye has been shown to result in reversal of glaucoma changes of the optic nerve in some patients. It has also been suggested that improvement in function (visual field) has been associated with improved optic nerve appearance.
This study seeks to provide evidence for reversal of disc appearance and visual function following IOP lowering interventions.
Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers in the retina and RNFL. This provides important anatomical information.
VEP (visual evoked potential) is an imaging system that measures electrical signals from the eye to the brain by using electrodes placed on the forehead and back of head. This is similar in principal to an electrocardiogram of the heart.
Visual field testing is done to evaluate the extent of side vision loss caused by various diseases of the eye, including glaucoma. This testing is performed as you stare at a small light directly in front of your eye while lights flash one at a time in every direction on a screen surrounding the central light. You push a button each time you see a flash out of the corner of your eye.
Lowering intraocular pressure (IOP) in the eye has been shown to result in reversal of glaucoma changes of the optic nerve in some patients. It has also been suggested that improvement in function (visual field) has been associated with improved optic nerve appearance.
This study seeks to provide evidence for reversal of disc appearance and visual function following IOP lowering interventions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: