Multiple SclerosisNCT03313843
Study to Assess OCT: RNFL and GCL in MS Patients
An observational study of Multiple Sclerosis, run by Tampa Bay Uveitis Center, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to collect preliminary data on retinal nerve fiber layer and ganglion cell layer damage in multiple sclerosis (MS) patients, using optical coherence tomography (OCT). For this study the Zeiss Cirrus OCT Imaging System will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2018to 30 Apr 2021
- 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: The study population will include patients meeting the diagnostic criteria of multiple sclerosis. Patients will be 18 years or older and pregnant women will be excluded. male and fmale patients will be recruited.
Who may be able to join
- Age 18 or older
- Pregnant women will be excluded by self declaration
- Male or female
- A diagnosis of MS, that meets the 2010 Revised McDonald Diagnostic Criteria
- A visual acuity of 20/400 or better in at least one eye
Who cannot join
- Any ocular disease than prevents assessment of the optic nerve and macula by OCT
- Advance glaucoma with optic nerve damage
- Any optic neuropathy not diagnosed as ON associated with MS
- A diagnosis of Macular Degeneration
- Any previous ocular trauma
- Any medical history of a cerebrovascular accident
Show all 9Show fewer
- Any planned ocular or systemic elective surgery during study duration
- Any contraindication to a comprehensive dilated ophthalmic examination
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tampa Bay Uveitis Center
New Port Richey, Florida, 34655
Tampa Bay Uveitis Center
Tampa, Florida, 33618
About this study
Official title: Prospective Cross Sectional Study To Assess The Clinical Utility of Optical Coherence Tomography to Measure Axonal Degeneration of the Optic Nerve, in a Cohort of 200 Subjects Meeting the Diagnostics Criteria of Multiple Sclerosis
The purpose of this study is to collect preliminary data on retinal nerve fiber layer and ganglion cell layer damage in multiple sclerosis (MS) patients, using optical coherence tomography (OCT). For this study the Zeiss Cirrus OCT Imaging System will be used. The same system will be used consistently for the duration of the study.
Read the detailed description
Hypothesis: Multiple sclerosis results in axonal degeneration which can be assessed objectively and non-invasively by serial OCT measurements of the RNFL and GCL.
This will be a prospective cross-sectional, non-interventional study; total recruitment will be 200 subjects. Recruitment will be stratified to enroll at least 50 subjects currently taking Lemtrada and 50 subjects with a documented diagnosis of ON. The study will enroll subjects primarily from practices in the Tampa Bay Area and adjacent counties. It is a planned non-interventional study; subjects will be followed by their neurologist and the study ophthalmologist and will receive standard of care. All subjects will have the ophthalmological examination and diagnostic measures, by the Principal Investigator, Dr. Grace Levy-Clarke, at Tampa Bay Uveitis Center.
Study Duration: The study duration will be 24 months, with an interim analysis at 50% recruitment status.
There are two primary aims of this longitudinal observational study:
- To determine whether atrophy within specific retinal layers over time is associated with clinical neurological progression of MS
- To determine whether an ON history affects the relationship described in aim # 1
Eye Exam: Subject will have an eye exam, including:
Visual Acuity Testing Color Vision Testing Automated perimetry/Peripheral Vision Testing Completing the National Eye Institute Visual Functioning Questionnaire (NEI/VFQ) Slit Lamp Examination Measurement of Intraocular Pressure (IOP) Dilated Fundus Examination (Ophthalmoscopy) Fundus Photography Optical Coherence Tomography: RNFL and Macular OCT
Neurologic Assessments: Must be performed no more than 60 days prior to screening/assessment Day 0 Ophthalmic Assessments
- Conditions
- Multiple Sclerosis
- Keywords
- Optical Coherence Tomography
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
Optical Coherence Tomography (OCT) will be used to assess change in RNFL of patients with multiple sclerosis
Measured: Assessed at Baseline then 6, 12, 18 and 24-month time points
Secondary outcomes (1)
Ganglion Cell Layer measurement (GCL: Macular OCT)
Optical Coherence Tomography (OCT) will be used to assess change in GCL of patients with multiple sclerosis
Measured: Assessed at Baseline then 6, 12, 18 and 24 - month time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start9 Feb 2018
- Primary completion17 Dec 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa Bay Uveitis Center, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Levy-Clarke, M.D., Principal investigator, Tampa Bay Uveitis Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313843
- Sponsor's protocol ID
- TBUC10022017
- Status last verified
- May 2021
- First submitted
- 9 Oct 2017
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cross Sectional Study To Assess The Clinical Utility of Optical Coherence Tomography to Measure Axonal Degeneration of the Optic Nerve, in a Cohort of 200 Subjects Meeting the Diagnostics Criteria of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03313843
- Acronym / sponsor ID
- TBUC10022017
- Conditions
- Multiple Sclerosis
- Keywords
- Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Tampa Bay Uveitis Center, LLCUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 Oct 2017 (actual)
- 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.
The purpose of this study is to collect preliminary data on retinal nerve fiber layer and ganglion cell layer damage in multiple sclerosis (MS) patients, using optical coherence tomography (OCT). For this study the Zeiss Cirrus OCT Imaging System will be used. The same system will be used consistently for the duration of the study.
Detailed description
Hypothesis: Multiple sclerosis results in axonal degeneration which can be assessed objectively and non-invasively by serial OCT measurements of the RNFL and GCL.
This will be a prospective cross-sectional, non-interventional study; total recruitment will be 200 subjects. Recruitment will be stratified to enroll at least 50 subjects currently taking Lemtrada and 50 subjects with a documented diagnosis of ON. The study will enroll subjects primarily from practices in the Tampa Bay Area and adjacent counties. It is a planned non-interventional study; subjects will be followed by their neurologist and the study ophthalmologist and will receive standard of care. All subjects will have the ophthalmological examination and diagnostic measures, by the Principal Investigator, Dr. Grace Levy-Clarke, at Tampa Bay Uveitis Center.
Study Duration: The study duration will be 24 months, with an interim analysis at 50% recruitment status.
There are two primary aims of this longitudinal observational study:
- To determine whether atrophy within specific retinal layers over time is associated with clinical neurological progression of MS
- To determine whether an ON history affects the relationship described in aim # 1
Eye Exam: Subject will have an eye exam, including:
Visual Acuity Testing Color Vision Testing Automated perimetry/Peripheral Vision Testing Completing the National Eye Institute Visual Functioning Questionnaire (NEI/VFQ) Slit Lamp Examination Measurement of Intraocular Pressure (IOP) Dilated Fundus Examination (Ophthalmoscopy) Fundus Photography Optical Coherence Tomography: RNFL and Macular OCT
Neurologic Assessments: Must be performed no more than 60 days prior to screening/assessment Day 0 Ophthalmic Assessments
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients meeting the diagnostic criteria of multiple sclerosis. Patients will be 18 years or older and pregnant women will be excluded. male and fmale patients will be recruited.
Key inclusion criteria (5 listed)
- Age 18 or older
- Pregnant women will be excluded by self declaration
- Male or female
- A diagnosis of MS, that meets the 2010 Revised McDonald Diagnostic Criteria
- A visual acuity of 20/400 or better in at least one eye
Key exclusion criteria (9 listed)
- Any ocular disease than prevents assessment of the optic nerve and macula by OCT
- Advance glaucoma with optic nerve damage
- Any optic neuropathy not diagnosed as ON associated with MS
- A diagnosis of Macular Degeneration
- Any previous ocular trauma
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
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
Time frame: Assessed at Baseline then 6, 12, 18 and 24-month time points
Optical Coherence Tomography (OCT) will be used to assess change in RNFL of patients with multiple sclerosis
1 secondary outcome
Ganglion Cell Layer measurement (GCL: Macular OCT)
Time frame: Assessed at Baseline then 6, 12, 18 and 24 - month time points
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 2 Jun 2021.
- 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.
Grace Levy-Clarke, M.D. principal investigator
Tampa Bay Uveitis Center, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Tampa Bay Uveitis Center, LLC at 2 sites 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 5 inclusion and 9 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT) (time frame: Assessed at Baseline then 6, 12, 18 and 24-month time points). 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 2 Jun 2021.