Trial Outcomes & Findings for Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure? (NCT NCT02600403)
NCT ID: NCT02600403
Last Updated: 2018-03-19
Results Overview
Visual field mean deviation as measured in decibels (dB) is the amount of visual field loss compared to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. Brighter light has lower number in decibels. The dimmer the light, the higher the number in decibels with a range of 0 to 40 dB.
Recruitment status
COMPLETED
Target enrollment
61 participants
Primary outcome timeframe
12 months
Results posted on
2018-03-19
Participant Flow
Participant milestones
| Measure |
Glaucoma Subjects With IOP 22-32 mmHg
Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).
Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.
Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.
Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With IOP >32 mmHg
Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).
This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.
Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.
Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.
Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).
Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.
Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.
Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.
Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
6
|
11
|
|
Overall Study
COMPLETED
|
44
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure?
Baseline characteristics by cohort
| Measure |
Glaucoma Subjects With Intra-ocular Pressure 22-32 mmHg
n=44 Participants
Forty four (44) patients will have testing done using optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF).
Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.
Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.
Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With Intra-ocular Pressure >32 mmHg
n=6 Participants
Six (6) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).
This testing will be repeated one (1) hour, one (1) day and three (3) months following the eye pressure lowering intervention.
Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.
Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.
Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
n=11 Participants
Eleven (11) patients will have testing done using optical coherence tomography (OCT), Visual Evoked Potential (VEP) and visual field (VF).
Testing will be repeated at 1-2 months, 4-6 months and 9-12 months after the initial testing was completed.
Optical Coherence Tomography (OCT): Optical Coherence Tomography (OCT) is a machine that scans the eyes and has the capability of measuring the thickness of the various layers of the retina and NFL.
Visual Evoked Potential (VEP): Visual Evoked Potential (VEP) is an imaging system that measures the electrical signal from the eye to the brain by using electrodes placed on the forehead and back of the head.
Visual Field: Visual field testing is done to evaluate the extent of side vision loss a patient has with various diseases of the eye, including glaucoma.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
65.5 years
n=7 Participants
|
60 years
n=5 Participants
|
64.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsVisual field mean deviation as measured in decibels (dB) is the amount of visual field loss compared to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. Brighter light has lower number in decibels. The dimmer the light, the higher the number in decibels with a range of 0 to 40 dB.
Outcome measures
| Measure |
Glaucoma Subjects With IOP 22-32 mmHg
n=44 Participants
Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With IOP >32 mmHg
n=6 Participants
Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
n=11 Participants
Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
|---|---|---|---|
|
Visual Field Mean Deviation
Pre-operative
|
-8.7 dB (decibels)
Standard Deviation 8.2
|
-13.3 dB (decibels)
Standard Deviation 9.7
|
-13.2 dB (decibels)
Standard Deviation 10.6
|
|
Visual Field Mean Deviation
Follow up 1
|
-8.3 dB (decibels)
Standard Deviation 7.84
|
-14.1 dB (decibels)
Standard Deviation 10.15
|
-8.6 dB (decibels)
Standard Deviation 7.87
|
|
Visual Field Mean Deviation
Follow up 2
|
-8.5 dB (decibels)
Standard Deviation 7.19
|
-13.8 dB (decibels)
Standard Deviation 10.66
|
-9.4 dB (decibels)
Standard Deviation 7.68
|
|
Visual Field Mean Deviation
Follow up 3
|
-9.4 dB (decibels)
Standard Deviation 8.5
|
-14.8 dB (decibels)
Standard Deviation 12.2
|
-10.4 dB (decibels)
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: 12 monthsRetinal nerve fiber layer (RNFL) thickness in different quadrants of optic nerve and macula are measured pre and postoperatively to evaluate structural changes.
Outcome measures
| Measure |
Glaucoma Subjects With IOP 22-32 mmHg
n=44 Participants
Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With IOP >32 mmHg
n=6 Participants
Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
n=11 Participants
Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
|---|---|---|---|
|
Retinal Nerve Fiber Layer (RNFL) Thickness Measurement
Pre-operative
|
75.5 um
Standard Deviation 16.1
|
74.3 um
Standard Deviation 10.2
|
70.4 um
Standard Deviation 11.7
|
|
Retinal Nerve Fiber Layer (RNFL) Thickness Measurement
Follow up 1
|
74.9 um
Standard Deviation 15.22
|
76 um
Standard Deviation 9.08
|
69.4 um
Standard Deviation 2.05
|
|
Retinal Nerve Fiber Layer (RNFL) Thickness Measurement
Follow up 2
|
73.8 um
Standard Deviation 20.53
|
75.2 um
Standard Deviation 9.75
|
68.9 um
Standard Deviation 0
|
|
Retinal Nerve Fiber Layer (RNFL) Thickness Measurement
Follow up 3
|
74.7 um
Standard Deviation 11.03
|
74.1 um
Standard Deviation 10.68
|
67.4 um
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 12 monthsCup to disc ratio is used to evaluate structural changes comparing the size of the cup to the size of the disc during dilated ophthalmic examination. High eye pressure can cause the cup to enlarge, closer to the size of the disc. This measurement is used to follow progression in glaucoma. A normal range for cup to disc ratio would be 0.0 to 0.4. Advanced glaucoma would be 0.8 to 0.9 cup to disc ratio.
Outcome measures
| Measure |
Glaucoma Subjects With IOP 22-32 mmHg
n=44 Participants
Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With IOP >32 mmHg
n=6 Participants
Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
n=11 Participants
Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
|---|---|---|---|
|
Average Cup to Disc Ratio
Pre-operative
|
0.71 ratio
Standard Deviation 0.12
|
0.76 ratio
Standard Deviation 0.17
|
0.76 ratio
Standard Deviation 0.09
|
|
Average Cup to Disc Ratio
Follow up 1
|
0.69 ratio
Standard Deviation 0.17
|
0.74 ratio
Standard Deviation 0.20
|
0.77 ratio
Standard Deviation 0.034
|
|
Average Cup to Disc Ratio
Follow up 2
|
0.68 ratio
Standard Deviation 0.20
|
0.72 ratio
Standard Deviation 0.19
|
0.75 ratio
Standard Deviation 0
|
|
Average Cup to Disc Ratio
Follow up 3
|
0.68 ratio
Standard Deviation 0.08
|
0.72 ratio
Standard Deviation 0.22
|
0.77 ratio
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: 12 monthsVEP amplitudes at high contrast as measured in microvolts (μV). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. The amplitude measurement is the peak of the energy generated (strongest strength of the signal) from the eye's response to the visual stimulus during the VEP.
Outcome measures
| Measure |
Glaucoma Subjects With IOP 22-32 mmHg
n=44 Participants
Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With IOP >32 mmHg
n=6 Participants
Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
n=11 Participants
Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
|---|---|---|---|
|
Visual Evoked Potential Amplitudes
Pre-operative Amplitude High Contrast
|
12.7 micro volts (uV)
Standard Deviation 14.4
|
10.7 micro volts (uV)
Standard Deviation 5.4
|
12.1 micro volts (uV)
Standard Deviation 8.33
|
|
Visual Evoked Potential Amplitudes
Follow up 1 Amplitude High Contrast
|
12.1 micro volts (uV)
Standard Deviation 6.73
|
9.5 micro volts (uV)
Standard Deviation 1.78
|
12.5 micro volts (uV)
Standard Deviation 8.6
|
|
Visual Evoked Potential Amplitudes
Follow up 2 Amplitude High Contrast
|
12.4 micro volts (uV)
Standard Deviation 3.34
|
9.2 micro volts (uV)
Standard Deviation 4.56
|
NA micro volts (uV)
Standard Deviation NA
values not calculated for visits 2 and 3 due to missing data. patients in this group did not return for all follow-up visits.
|
|
Visual Evoked Potential Amplitudes
Follow up 3 Amplitude High Contrast
|
11.8 micro volts (uV)
Standard Deviation 4.3
|
12.1 micro volts (uV)
Standard Deviation 5.5
|
NA micro volts (uV)
Standard Deviation NA
values not calculated for visits 2 and 3 due to missing data
|
PRIMARY outcome
Timeframe: 12 monthsVEP latency at high contrast as measured in milliseconds (ms). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. VEP latencies measure the duration in time of the energy generated (duration of the signal) from the eye's response to a visual stimulus during the VEP.
Outcome measures
| Measure |
Glaucoma Subjects With IOP 22-32 mmHg
n=44 Participants
Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With IOP >32 mmHg
n=6 Participants
Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
n=11 Participants
Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
|---|---|---|---|
|
Visual Evoked Potential Latency
Pre-operative
|
126.1 Milli-seconds (ms)
Standard Deviation 14.67
|
117.0 Milli-seconds (ms)
Standard Deviation 20.25
|
114.1 Milli-seconds (ms)
Standard Deviation 19.70
|
|
Visual Evoked Potential Latency
Follow up 1 Latency High Contrast
|
110.1 Milli-seconds (ms)
Standard Deviation 18.56
|
125.7 Milli-seconds (ms)
Standard Deviation 3.40
|
139.8 Milli-seconds (ms)
Standard Deviation 1.95
|
|
Visual Evoked Potential Latency
Follow up 2 Latency High Contrast
|
123.1 Milli-seconds (ms)
Standard Deviation 19.95
|
124.2 Milli-seconds (ms)
Standard Deviation 13.36
|
NA Milli-seconds (ms)
Standard Deviation NA
values not calculated for visits 2 and 3 due to missing data
|
|
Visual Evoked Potential Latency
Follow up 3 Latency High Contrast
|
118.8 Milli-seconds (ms)
Standard Deviation 3.23
|
127.5 Milli-seconds (ms)
Standard Deviation 13.76
|
NA Milli-seconds (ms)
Standard Deviation NA
values not calculated for visits 2 and 3 due to missing data
|
PRIMARY outcome
Timeframe: 12 monthsVisual field pattern standard deviation in decibels (dB). Visual field results compare visual field loss to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. With a localized defect in the visual field, pattern standard deviation (PSD) quantifies amount of loss and progression of glaucoma when in the beginning stages of the disease.
Outcome measures
| Measure |
Glaucoma Subjects With IOP 22-32 mmHg
n=44 Participants
Forty four (44) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Glaucoma Subjects With IOP >32 mmHg
n=6 Participants
Six (6) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
Control Glaucoma Subjects
n=11 Participants
Eleven (11) patients will have optical coherence tomography (OCT), visual evoked potential (VEP) and visual field (VF) repeated at 1-2 months, 4-6 months and 9-12 months after initial eye pressure intervention (follow-up testing will be one (1) visual field test, two (2) OCT's and one (1) VEP).
Optical Coherence Tomography (OCT): is a series of eye scans with capability of measuring thickness of the various layers of the retina and RNFL.
Visual Evoked Potential (VEP): is a system that measures electrical signals from the eye to the brain by electrodes placed on the forehead and back of the head.
Visual Field: testing is done to evaluate extent of side vision loss from various diseases of the eye, including glaucoma.
|
|---|---|---|---|
|
Visual Field
Pre-operative
|
4.9 dB
Standard Deviation 3.57
|
6.3 dB
Standard Deviation 3.33
|
6.8 dB
Standard Deviation 3.99
|
|
Visual Field
Follow up 1
|
5.0 dB
Standard Deviation 3.54
|
4.0 dB
Standard Deviation 2.95
|
5.8 dB
Standard Deviation 4.42
|
|
Visual Field
Follow up 2
|
5.1 dB
Standard Deviation 3.63
|
5.0 dB
Standard Deviation 2.97
|
6.7 dB
Standard Deviation 4.80
|
|
Visual Field
Follow up 3
|
5.0 dB
Standard Deviation 4.00
|
4.1 dB
Standard Deviation 2.25
|
6.4 dB
Standard Deviation 5.04
|
Adverse Events
Glaucoma Subjects With IOP 22-32 mmHg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucoma Subjects With IOP >32 mmHg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Glaucoma Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place