Macular DegenerationNCT02225119
The Focal Electro-Oculogram in Macular Disease
An observational study of Macular Degeneration and Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 100 years
- Conditions the study is for
- Macular Degeneration, Age-Related Macular Degeneration
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2015to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 50 healthy volunteers and 80 participants, age 10 or older, with macular disease; examples of such disorders include Stargardt s disease and age-related macular degeneration (AMD). NIH employees meeting the eligibility criteria may participate in this study.
Who may be able to join
- Participant must be 10 years of age or older.
- Participant (or legal guardian) must understand and sign the protocol s informed consent document.
- Participant must be able to cooperate with the testing required for this study.
- For Participants with macular disease only:
- Participant must have macular disease, defined as evidence of loss of centrally mediated retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging.
- Participant must have a measurable visual acuity.
- For Healthy Volunteers only:
- Participant must have visual acuity of 20/20 or better in at least one eye.
Who cannot join
- 1) Participant with pre-retinal media opacities that would prevent focal light presentation.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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 20/20 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.
Read the 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 retina/retinal 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.
- Keywords
- Retinal Images, Retinal Pigment Epithelium, Natural History
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected | Participants with macular disease | |
| Unaffected | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
develop method for recording focal EOG
to develop a method for recording the focal EOG in response to a central light stimulus
Measured: up to 6 months
Secondary outcomes (1)
establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test
establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start6 Feb 2015
- Primary completion7 May 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brett G Jeffrey, Ph.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225119
- Sponsor's protocol ID
- 140171
- Other IDs
- 14-EI-0171
- Status last verified
- Dec 2024
- First submitted
- 23 Aug 2014
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Focal Electro-Oculogram in Macular Disease
- ClinicalTrials.gov ID
- NCT02225119
- Acronym / sponsor ID
- 140171
- Keywords
- Retinal Images, Retinal Pigment Epithelium, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 20/20 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 retina/retinal 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected | – | –Participants with macular disease |
| Unaffected | – | –Healthy volunteers |
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 50 healthy volunteers and 80 participants, age 10 or older, with macular disease; examples of such disorders include Stargardt s disease and age-related macular degeneration (AMD). NIH employees meeting the eligibility criteria may participate in this study.
Key inclusion criteria (8 listed)
Key exclusion criteria (1 listed)
- 1) Participant with pre-retinal media opacities that would prevent focal light presentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
develop method for recording focal EOG
Time frame: up to 6 months
to develop a method for recording the focal EOG in response to a central light stimulus
1 secondary outcome
establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett G Jeffrey, Ph.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration and Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
develop method for recording focal EOG (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.