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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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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OCT VEP VF

Eligibility Criteria

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Inclusion Criteria

* All patients with glaucoma (primary open-angle glaucoma, angle recession glaucoma, exfoliation syndrome glaucoma, pigmentary glaucoma and chronic angle closure glaucoma) in whom a pressure-lowering intervention was conducted

Exclusion Criteria

* Inability to obtain reliable field or optical coherence tomography pre-intervention
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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George L. Spaeth MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type BACKGROUND
PMID: 21599873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26995555 (View on PubMed)

Other Identifiers

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11-058

Identifier Type: -

Identifier Source: org_study_id

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