Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02225119
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2014-08-23
Brief Title:
The Focal Electro-Oculogram in Macular Disease
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Focal Electro-Oculogram in Macular Disease
Status:
COMPLETED
Status Verified Date:
2024-09-17
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:
Background
- Maculopathies are eye conditions that affect the center of the retina Retina health depends on the retinal pigment epithelium RPE a layer behind the retina A new test may measure the health of the central retina and RPE
Objective
- To use the focal electro-oculogram EOG test to understand how the central retina and RPE are affected in maculopathies
Eligibility
People at least 10 years old with a maculopathy
Healthy volunteers with visual acuity of 2020 or better in at least one eye
Design
Participants will be screened with medical and eye history and an eye exam Pictures will be taken of the eyes
Their eyes may be dilated
They may have a field test They will look into a lens and press a button when they see a light First they may sit in the dark for 40 minutes
Participants will have 1-7 visits over 18 months
Their vision will be tested and eye pressure measured
Their pupils will be dilated with eye drops and researchers may take pictures of the retina and the inside of the eye and measure the thickness of the retina
Participants will have an electro-oculogram They will look at a 2 LED lights and follow them back and forth for 10 seconds once per minute Participants will be in darkness for 15 minutes and in light for 20 minutes One skin electrode will be placed on the nose and one next to the eye
Participants with maculopathy will also have
Field test
Electroretinogram Participants will get numbing eye drops and special contact lenses A small metal electrode will be taped to the forehead Participants will watch flashing lights and try not to blink First they may sit in the dark for 40 minutes
- Maculopathies are eye conditions that affect the center of the retina Retina health depends on the retinal pigment epithelium RPE a layer behind the retina A new test may measure the health of the central retina and RPE
Objective
- To use the focal electro-oculogram EOG test to understand how the central retina and RPE are affected in maculopathies
Eligibility
People at least 10 years old with a maculopathy
Healthy volunteers with visual acuity of 2020 or better in at least one eye
Design
Participants will be screened with medical and eye history and an eye exam Pictures will be taken of the eyes
Their eyes may be dilated
They may have a field test They will look into a lens and press a button when they see a light First they may sit in the dark for 40 minutes
Participants will have 1-7 visits over 18 months
Their vision will be tested and eye pressure measured
Their pupils will be dilated with eye drops and researchers may take pictures of the retina and the inside of the eye and measure the thickness of the retina
Participants will have an electro-oculogram They will look at a 2 LED lights and follow them back and forth for 10 seconds once per minute Participants will be in darkness for 15 minutes and in light for 20 minutes One skin electrode will be placed on the nose and one next to the eye
Participants with maculopathy will also have
Field test
Electroretinogram Participants will get numbing eye drops and special contact lenses A small metal electrode will be taped to the forehead Participants will watch flashing lights and try not to blink First they may sit in the dark for 40 minutes
Detailed Description:
OBJECTIVE
The objective of this protocol is to investigate the local response of the retinal pigment epithelium RPE across the posterior pole of the eye by recording the focal electrooculogram EOG in participants with macular disease
STUDY POPULATION
Up to 50 healthy volunteers and 80 participants age 10 or older with macular disorders affecting the retinaretinal pigment epithelium complex Examples of such macular disorders include Stargardt s disease and age-related macular degeneration AMD
DESIGN
This single-center observational case-control study will be comprised of three related aims The first aim is focused on developing the focal EOG method which will require parameter optimization The second aim is focused on establishing the normal range and variability of the focal EOG in normal volunteers The third aim is to examine the focal EOG in participants with macular disease
OUTCOME MEASURES
The primary outcome for this study is to develop a method for recording the focal EOG The secondary outcome will be to establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test Exploratory outcomes include 1 to examine the focal EOG in participants with macular diseases and 2 determine the inter-session and intra-session variabilities of this test in participants with macular diseases
The objective of this protocol is to investigate the local response of the retinal pigment epithelium RPE across the posterior pole of the eye by recording the focal electrooculogram EOG in participants with macular disease
STUDY POPULATION
Up to 50 healthy volunteers and 80 participants age 10 or older with macular disorders affecting the retinaretinal pigment epithelium complex Examples of such macular disorders include Stargardt s disease and age-related macular degeneration AMD
DESIGN
This single-center observational case-control study will be comprised of three related aims The first aim is focused on developing the focal EOG method which will require parameter optimization The second aim is focused on establishing the normal range and variability of the focal EOG in normal volunteers The third aim is to examine the focal EOG in participants with macular disease
OUTCOME MEASURES
The primary outcome for this study is to develop a method for recording the focal EOG The secondary outcome will be to establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test Exploratory outcomes include 1 to examine the focal EOG in participants with macular diseases and 2 determine the inter-session and intra-session variabilities of this test in participants with macular diseases
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-EI-0171 | None | None | None |