UveitisNCT02311192
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography
A study testing Ultrasonography B-scan in people with Uveitis, run by University of Nebraska.
Trial summary
This study is aimed at creation and validation of a vitreous haze scoring system using ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and quantification of inflammation will be done to create the scoring scale. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Ultrasonography B-scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 30 Sep 2016
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age 18 -90 years
- Diagnosis of uveitis
Who cannot join
- • Patients with posterior segment complications including retinal detachment, choroidal detachment or hemorrhage
- Patients with any intraocular foreign body or displaced intraocular lens
- Patients with silicon oil filled eye or with gas tamponade.
- Patients with vitreous hemorrhage
- Patients with media opacity including visually significant cataract that precludes grading of VH based on fundus photography
About this study
This study is aimed at creation and validation of a vitreous haze scoring system using ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and quantification of inflammation will be done to create the scoring scale.
Read the detailed description
Patients with uveitis may present with Vitreous Haze (VH) resulting in obscuration of fundus details. VH is composed of cells and protein exudation and results in decrease visual acuity.The degree of VH is an important indicator of disease activity, severity and response to therapy in patients with uveitis. Color fundus images are commonly used to objectively document VH.
- Conditions
- Uveitis
- Being tested
- Ultrasonography B-scan
- Keywords
- Vitreous Haze, Ocular ultrasound, B scan, Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography B-scanDevice
The patient's eye will be anesthetized. The ultrasound probe will then be used to obtain images by keeping the probe in light contact with the eye.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography B-scan | Experimental | Patients of uveitis who are included in the study will be imaged using ultrasound B-scan Receives: Device: Ultrasonography B-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer correlation for vitreous haze grading
Inter-observer correlation for vitreous haze (VH) grading will be assessed using number of eyes as the unit of measure as well as standardized grading scheme for VH
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start1 Oct 2014
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Why it stopped: Department chair choose not to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Luigi Sacco University Hospital
- Responsible party
- Sponsor
- Investigators
- Quan D Nguyen, MD MSc, Principal investigator, University of NebraskaGiovanni Staurenghi, MD, Principal investigator, Luigi Sacco HospitalRamandeep Singh, MS, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311192
- Sponsor's protocol ID
- 0583-14-EP
- Status last verified
- Aug 2023
- First submitted
- 4 Dec 2014
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography
- ClinicalTrials.gov ID
- NCT02311192
- Acronym / sponsor ID
- 0583-14-EP
- Conditions
- Uveitis
- Keywords
- Vitreous Haze, Ocular ultrasound, B scan, Uveitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Department chair choose not to participate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Luigi Sacco University Hospital
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 8 Dec 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.
This study is aimed at creation and validation of a vitreous haze scoring system using ultrasonography B-scan of the eye. Images will be obtained from patients with uveitis and quantification of inflammation will be done to create the scoring scale.
Detailed description
Patients with uveitis may present with Vitreous Haze (VH) resulting in obscuration of fundus details. VH is composed of cells and protein exudation and results in decrease visual acuity.The degree of VH is an important indicator of disease activity, severity and response to therapy in patients with uveitis. Color fundus images are commonly used to objectively document VH.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography B-scan | Experimental | Device: Ultrasonography B-scanPatients of uveitis who are included in the study will be imaged using ultrasound B-scan |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Ability to provide written informed consent and comply with study assessments for the full duration of the study
Key exclusion criteria (5 listed)
- • Patients with posterior segment complications including retinal detachment, choroidal detachment or hemorrhage
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 |
|---|---|---|
| Ultrasonography B-scanThe patient's eye will be anesthetized. The ultrasound probe will then be used to obtain images by keeping the probe in light contact with the eye. | Device | Ultrasonography B-scan |
Primary outcome
Inter-observer correlation for vitreous haze grading
Time frame: 1 year
Inter-observer correlation for vitreous haze (VH) grading will be assessed using number of eyes as the unit of measure as well as standardized grading scheme for VH
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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.
Quan D Nguyen, MD MSc principal investigator
University of Nebraska
Giovanni Staurenghi, MD principal investigator
Luigi Sacco Hospital
Ramandeep Singh, MS principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography B-scan in people with Uveitis, run by University of Nebraska.
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 5 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: withdrawn, as of the sponsor's last update on 15 Aug 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Inter-observer correlation for vitreous haze grading (time frame: 1 year). 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 15 Aug 2023.