Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography

Uveitis Clinical Trial

Official title:

Grading Scale of Vitreous Haze in Patients With Uveitis Using Ultrasonography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02311192
• Other study ID #: 0583-14-EP
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: September 30, 2016

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Uveitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Nebraska	Luigi Sacco University Hospital, Postgraduate Institute of Medical Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year