Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography

August 11, 2023 updated by: University of Nebraska
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonography B-scan
Patients of uveitis who are included in the study will be imaged using ultrasound B-scan
Device: Ultrasonography B-scan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Postgraduate Institute of Medical Education and Research
Luigi Sacco University Hospital

Investigators

  • Principal Investigator: Quan D Nguyen, MD MSc, University of Nebraska
  • Principal Investigator: Giovanni Staurenghi, MD, Luigi Sacco Hospital
  • Principal Investigator: Ramandeep Singh, MS, Post Graduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimated)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0583-14-EP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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