NCT02311192

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

December 4, 2014

Last Update Submit

August 11, 2023

Conditions

Uveitis

Keywords

Vitreous HazeOcular ultrasoundB scanUveitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Ultrasonography B-scan

EXPERIMENTAL

Patients of uveitis who are included in the study will be imaged using ultrasound B-scan

Device: Ultrasonography B-scan

Interventions

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.

Ultrasonography B-scan

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • 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, Chandigarh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

October 1, 2014

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

August 15, 2023

Record last verified: 2023-08