Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure?
NCT ID: NCT02600403
Last Updated: 2018-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
61 participants
OBSERVATIONAL
2011-10-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IOP between 22-32 mmHg
Forty four (44) patients with intraocular pressure between 22 and 32 millimeters (mmHg) of mercury will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF).
Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers of the retina and nerve fiber layer (NFL).
Visual evoked potential (VEP)
Visual Evoked Potential (VEP) is an imaging system that measures electrical activity from the eye to the brain by using electrodes placed on forehead and back of the head similar to electroencephalogram (EEG).
Humphrey Visual Field (HVF)
Humphrey Visual Field (HVF) is a test done to evaluate how much peripheral (side) vision has been lost due to glaucoma.
IOP greater than 32 mmHg
Six (6) patients with intraocular pressure greater than 32 millimeters of mercury (mmHg) will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF).
Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers of the retina and nerve fiber layer (NFL).
Visual evoked potential (VEP)
Visual Evoked Potential (VEP) is an imaging system that measures electrical activity from the eye to the brain by using electrodes placed on forehead and back of the head similar to electroencephalogram (EEG).
Humphrey Visual Field (HVF)
Humphrey Visual Field (HVF) is a test done to evaluate how much peripheral (side) vision has been lost due to glaucoma.
IOP less than 22 mmHg
Eleven (11) patients with stable intraocular pressure (less than 22 millimeters of mercury (mmHg)) on ophthalmic solutions (eye drops) will undergo Optical Coherence Tomography (OCT); Visual Evoked Potential (VEP); and Humphrey Visual Field (HVF).
Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers of the retina and nerve fiber layer (NFL).
Visual evoked potential (VEP)
Visual Evoked Potential (VEP) is an imaging system that measures electrical activity from the eye to the brain by using electrodes placed on forehead and back of the head similar to electroencephalogram (EEG).
Humphrey Visual Field (HVF)
Humphrey Visual Field (HVF) is a test done to evaluate how much peripheral (side) vision has been lost due to glaucoma.
Interventions
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Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers of the retina and nerve fiber layer (NFL).
Visual evoked potential (VEP)
Visual Evoked Potential (VEP) is an imaging system that measures electrical activity from the eye to the brain by using electrodes placed on forehead and back of the head similar to electroencephalogram (EEG).
Humphrey Visual Field (HVF)
Humphrey Visual Field (HVF) is a test done to evaluate how much peripheral (side) vision has been lost due to glaucoma.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Visual acuity less than 20/40,
* Age \<18 or \>90 years,
* Other cause for visual field loss not glaucoma, that is, visual field loss due to cataract optic neuropathies, retinal disease
* Spherical equivalent refractive error \> +5.00 Diopters and \> 3.00 Diopters cylinder
* Concomitant cataract and glaucoma surgery
18 Years
90 Years
ALL
No
Sponsors
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Wills Eye
OTHER
Responsible Party
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George L. Spaeth MD
MD
Principal Investigators
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George Spaeth, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye
References
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Jindal AP, Fleischman D, Leiby B, Spaeth GL, Myers JS, Katz LJ. Effects of acutely lowering intraocular pressure on the results of multifocal visual evoked potential testing. Acta Ophthalmol. 2011 Nov;89(7):e550-4. doi: 10.1111/j.1755-3768.2011.02177.x. Epub 2011 May 23.
Waisbourd M, Ahmed OM, Molineaux J, Gonzalez A, Spaeth GL, Katz LJ. Reversible structural and functional changes after intraocular pressure reduction in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2016 Jun;254(6):1159-66. doi: 10.1007/s00417-016-3321-2. Epub 2016 Mar 19.
Other Identifiers
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11-058
Identifier Type: -
Identifier Source: org_study_id
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