Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388096
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-22
Brief Title:
CLAD Deconvolved PERG Responses in Glaucoma Patients
Sponsor:
Jorvec Corp
Organization:
Jorvec Corp
Study Overview
Official Title:
CLAD Deconvolved PERG Responses in Glaucoma Patients
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Glaucoma is a progressive disease resulting in blindness Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision This study will collect data from a population of glaucoma suspects with positive factors for the disease but with normal vision along with a population of age matched controls using the pattern electroretinogram PERG and other standard eye tests for glaucoma The PERG measures the function of retinal ganglion cells RGCs which come together to form the optic nerve RGCs may become dysfunctional before dying The Continuous loop deconvolution technique CLAD will be used to extract transient PERG responses in both glaucoma suspects and age matched controls All patients will be monitored with PERG Optic Coherence Tomography OCT and other ancillary tests over 2 years CLAD will be compared with conventional techniques of monitoring glaucoma standard PERG OCT visual field etc to see if the CLAD is better at distinguishing between glaucoma suspects and controls
Detailed Description:
The PERG is recorded from small metallic cups taped on the skin or contact electrodes on the face similarly to an electrocardiogram except that the location is the skin around the eyes
The only physical contact the subject will experience is a gentle cleaning of the skin with an alcohol prep pad During the test the subject will be asked to look at a visual stimulus display for about 3 minutes Depending on the experimental protocol the subject may be asked to either sit during the test or to lie down in a bed Lying down 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 will be dilated with drops similar to those used in a standard eye exam The subject will have to briefly look at a mark inside the instrument one eye at a time
For Visual field VF evaluation the subject will be asked to look at a fixation mark inside the Visual Field testing equipment and asked to signal when they see small lights in their periphery
PERG OCT and VF will be performed during the same day of the visit If the participant has already done these tests in the past as part of another study or as part of standard treatment the results of these tests will be obtained from shier record and be included in this study
RISKS
For the PERG the only significant risk to you is a small chance of skin discomfort from 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 There are no significant risks associated with VF testing
The only physical contact the subject will experience is a gentle cleaning of the skin with an alcohol prep pad During the test the subject will be asked to look at a visual stimulus display for about 3 minutes Depending on the experimental protocol the subject may be asked to either sit during the test or to lie down in a bed Lying down 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 will be dilated with drops similar to those used in a standard eye exam The subject will have to briefly look at a mark inside the instrument one eye at a time
For Visual field VF evaluation the subject will be asked to look at a fixation mark inside the Visual Field testing equipment and asked to signal when they see small lights in their periphery
PERG OCT and VF will be performed during the same day of the visit If the participant has already done these tests in the past as part of another study or as part of standard treatment the results of these tests will be obtained from shier record and be included in this study
RISKS
For the PERG the only significant risk to you is a small chance of skin discomfort from 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 There are no significant risks associated with VF testing
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None