Optic Nerve DisordersNCT02382627
Choroidal Thickness in Optic Neuropathy
An observational study of Optic Nerve Disorders, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the thickness of the choroid in patients with optic neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Nerve Disorders
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients with optic neuropathy seen in the ophthalmology or neuro-ophthalmology clinics at the University of Colorado will be enrolled in this study.
Who may be able to join
- age greater than 18 years,
- diagnosis of optic neuropathy,
- willing and able to sign an informed consent.
Who cannot join
- steroid use within the past 4 weeks,
- inability to cooperate with optical coherence tomography (OCT) testing,
- relevant ocular comorbidities in the affected or unaffected eye, such as
- glaucoma,
- uveitis,
- optic nerve hypoplasia,
- age related macular degeneration,
- refractive error greater than 5 spherical diopters.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
This study plans to learn more about the thickness of the choroid in patients with optic neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. Patients are being asked to be in this research study because they have optic neuropathy and are receiving care at the University of Colorado Hospital.
- Conditions
- Optic Nerve Disorders
- Medical subject headings
- Optic Nerve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the subfoveal and parafoveal choroidal thickness in affected and unaffected eye of the same patient.
Measured: 1 time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve DisordersStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Bennett, MD, Principal investigator, 303-724-6450
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382627
- Sponsor's protocol ID
- 14-2348
- Status last verified
- Oct 2019
- First submitted
- 2 Mar 2015
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Thickness in Optic Neuropathy
- ClinicalTrials.gov ID
- NCT02382627
- Acronym / sponsor ID
- 14-2348
- Conditions
- Optic Nerve Disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Mar 2015 (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.
This study plans to learn more about the thickness of the choroid in patients with optic neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. Patients are being asked to be in this research study because they have optic neuropathy and are receiving care at the University of Colorado Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients with optic neuropathy seen in the ophthalmology or neuro-ophthalmology clinics at the University of Colorado will be enrolled in this study.
Key inclusion criteria (3 listed)
- age greater than 18 years,
- diagnosis of optic neuropathy,
- willing and able to sign an informed consent.
Key exclusion criteria (8 listed)
- steroid use within the past 4 weeks,
- inability to cooperate with optical coherence tomography (OCT) testing,
- relevant ocular comorbidities in the affected or unaffected eye, such as
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
Difference of the subfoveal and parafoveal choroidal thickness in affected and unaffected eye of the same patient.
Time frame: 1 time
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
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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.
Jeffrey Bennett, MD principal investigator
303-724-6450
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 Optic Nerve Disorders, run by University of Colorado, Denver 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Oct 2019. 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 was stopped early (reason given: poor enrollment). Results are not available in the source record.
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?
Difference of the subfoveal and parafoveal choroidal thickness in affected and unaffected eye of the same patient. (time frame: 1 time). 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 18 Oct 2019.