Back to resultsGrading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography
Primary Purpose
Uveitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasonography B-scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Uveitis focused on measuring Vitreous Haze, Ocular ultrasound, B scan, Uveitis
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasonography B-scan
Arm Description
Patients of uveitis who are included in the study will be imaged using ultrasound B-scan
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02311192
First Posted
December 4, 2014
Last Updated
August 11, 2023
Sponsor
University of Nebraska
Collaborators
Postgraduate Institute of Medical Education and Research, Luigi Sacco University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02311192
Brief Title
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography
Official Title
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Department chair choose not to participate
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Postgraduate Institute of Medical Education and Research, Luigi Sacco University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
Vitreous Haze, Ocular ultrasound, B scan, Uveitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasonography B-scan
Arm Type
Experimental
Arm Description
Patients of uveitis who are included in the study will be imaged using ultrasound B-scan
Intervention Type
Device
Intervention Name(s)
Ultrasonography B-scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inter-observer correlation for vitreous haze grading
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan D Nguyen, MD MSc
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giovanni Staurenghi, MD
Organizational Affiliation
Luigi Sacco Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramandeep Singh, MS
Organizational Affiliation
Post Graduate Institute of Medical Education and Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography
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