Thyroid Associated OphthalmopathyNCT02766660
Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
A study testing Optical Coherence Tomography in people with Thyroid Associated Ophthalmopathy, run by Neon Hospital.
Trial summary
The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls. Read more about this study
- Who is it for?
- Ages 12 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2013
- Phase
- Interventional
- 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 12 to 73 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- For both groups, those who had
- significant sight impairment,
- high myopia ( < -5Diopters ),
- high hyperopia ( > +3Diopters ),
- optic disc anomaly,
- vitreoretinal interface disease,
Show all 14Show fewer
- vascular and degenerative retinal diseases,
- cornea or lens opacity, ocular surgery history,
- glaucoma,
- neurological diseases that can affect the visual field,
- history of trauma, amblyopia,
- diplopia,
- keratitis,
- history of topical or systemic steroid
About this study
The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls.
Read the detailed description
One hundred and thirty two eyes of 66 patients with TAO and 72 eyes of 36 healthy controls were included in the study. Proptosis level was determined by Hertel exophthalmometer. Optic disc, peripapillary retinal nerve fiber layer and macula parameters were measured by OCT. All measurements were compared between the patients and age and sex-matched healthy controls.
- Conditions
- Thyroid Associated Ophthalmopathy
- Being tested
- Optical Coherence Tomography
- Keywords
- Thyroid ophthalmopathy, optical coherence tomography
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
All groups were measured by optical coherence tomography.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid ophthalmopathy | Other | Thyroid associated ophthalmopathy patients were measured by optical coherence tomography. Receives: Device: Optical Coherence Tomography |
| Control | Other | Control group was consisted by age and sex- macthed healthy people adn they were measured by optical coherence tomography. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness
Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.
Measured: one year (between Jan 2012 and Jan 2013)
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness (micrometer) was measured by optical coherence tomography in patient and control groups.
Measured: one year (between Jan 2012 and Jan 2013)
Secondary outcomes (1)
Optic disc parameters
Optic disc parameters (morphologic structures) were obtained by optical coherence tomography for both groups.
Measured: one year (between Jan 2012 and Jan 2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Associated OphthalmopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Sponsor
- Investigators
- Nurşen ARITÜRK, Prof., Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766660
- Sponsor's protocol ID
- 2013-379
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sayin O, Yeter V, Ariturk N. Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid-Associated Ophthalmopathy. J Ophthalmol. 2016;2016:9452687. doi: 10.1155/2016/9452687. Epub 2016 Jul 17.
PubMed 27493796
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT02766660
- Acronym / sponsor ID
- 2013-379
- Conditions
- Thyroid Associated Ophthalmopathy
- Keywords
- Thyroid ophthalmopathy, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Neon HospitalUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 May 2016 (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.
The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls.
Detailed description
One hundred and thirty two eyes of 66 patients with TAO and 72 eyes of 36 healthy controls were included in the study. Proptosis level was determined by Hertel exophthalmometer. Optic disc, peripapillary retinal nerve fiber layer and macula parameters were measured by OCT. All measurements were compared between the patients and age and sex-matched healthy controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid ophthalmopathy | Other | Device: Optical Coherence TomographyThyroid associated ophthalmopathy patients were measured by optical coherence tomography. |
| Control | Other | Device: Optical Coherence TomographyControl group was consisted by age and sex- macthed healthy people adn they were measured by optical coherence tomography. |
Who may qualify
- Ages
- 12 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- For both groups, those who had
- significant sight impairment,
- high myopia ( < -5Diopters ),
- high hyperopia ( > +3Diopters ),
- optic disc anomaly,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence TomographyAll groups were measured by optical coherence tomography. | Device | Control, Thyroid ophthalmopathy |
Primary outcome
Macular thickness
Time frame: one year (between Jan 2012 and Jan 2013)
Macular thickness (micrometer) was measured by optical coherence tomography in patients and controls.
Retinal nerve fiber layer thickness
Time frame: one year (between Jan 2012 and Jan 2013)
Retinal nerve fiber layer thickness (micrometer) was measured by optical coherence tomography in patient and control groups.
1 secondary outcome
Optic disc parameters
Time frame: one year (between Jan 2012 and Jan 2013)
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 10 May 2016.
- Derived from this study: PubMed 27493796Sayin O, Yeter V, Ariturk N. Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid-Associated Ophthalmopathy. J Ophthalmol. 2016;2016:9452687. doi: 10.1155/2016/9452687. Epub 2016 Jul 17.
- Individual participant dataSharing planned: No
Related trials for Thyroid Associated Ophthalmopathy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Graves Disease, Graves Disease (Basedow's Disease)
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.
Nurşen ARITÜRK, Prof. principal investigator
Ondokuz Mayıs University
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography in people with Thyroid Associated Ophthalmopathy, run by Neon Hospital.
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 0 inclusion and 14 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Macular thickness (time frame: one year (between Jan 2012 and Jan 2013)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766660, which also lists 1 linked publication.
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 10 May 2016.