Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02390284 |
| Other study ID # |
20140587 |
| Secondary ID |
R01EY014957 |
| Status |
Active, not recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
July 2024 |
Study information
| Verified date |
November 2023 |
| Source |
University of Miami |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the
disease, predicting its severity and the benefit of pressure lowering eye drops is key to
clinical management aimed at maintaining useful vision with advancing age. This study will
longitudinally monitor a population of glaucoma suspects (with positive factors for the
disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other
standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells
(RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before
dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with
abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG
will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography
(OCT) and other ancillary tests every 6 months over 4 years.
Description:
The PERG is recorded from small metallic buttons taped on the skin similarly to an
electrocardiogram, with the difference that the electrodes are around the eyes.
The only physical contact you will experience is a gentle cleaning of the skin with an
alcohol prep pad. During the test you must look with both eyes at a Television (TV) display
for about 3 minutes. During the follow up period you may be asked to take one more PERG test
lying down in a bed.
This will cause a momentary increase of your eye pressure similar to the one that occurs
during your normal sleep. This may help to understand whether or not your optic nerve
functions normally when the pressure in your eye increases. For OCT evaluation, the pupil has
to be dilated with drops as you did before for your eye exam. You have to briefly look at a
mark inside the instrument one eye at a time.
PERG and OCT will be performed during the same day of your visit with the eye doctor. If you
have already done these tests in the past, as part of another study or as part of your
standard treatment, the results of these tests will be obtained from your record, and be
included in this study.
If you are a participant in the Observation Group, you will be monitored with PERG, OCT, and
standard clinical examinations every six months until close of study. If you are a
participant in the Medication Group you will be also treated with eye drop medicines.
RISKS:
There are certain risks and discomforts that may be associated with this research. You should
be aware that you are at risk of developing glaucoma whether you participate in the study or
not. It is not known whether the risk of developing glaucoma is reduced by eye drops to lower
eye pressure; the study will attempt to answer this question.
For the PERG, the only significant risk to you is a small chance of a rash to the cleansing
agent for skin electrodes, which should go away without treatment. For OCT, there is a rare
risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even
lower if you did not have any reaction during your previous eye exams. In case of an allergic
reaction, your eye doctor will immediately treat it. If you had previous problems with pupil
dilation, you may wish to speak to your eye doctor about the option of doing this additional
test.
