Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.

August 29, 2014 updated by: Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology
The purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 20 patients will be included. 10 patients with uveitis and 10 control patients scheduled for phacoemulsification. Each patient will undego complete ophthalmic examination and clinical biomicroscopic grading of the anterior chamber flare applying the SUN working group grading system. Aqueous specimens will be obtained by anterior chamber paracentesis for protein analysis. Each Patient will undego paracentesis and 0.2 ml of aqueous will be obtained. The aqueous sample will be stored at -70°C until the time of analysis for protein content. Objective assessment of flare will be done.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 10 patients with uveitis with cataract
  • 10 patients without uveitis with cataract
  • Inactive inflammation for at least 3 months

Exclusion Criteria:

  • Infectious uveitis
  • endophthalmitis
  • cases with corneal scar

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with uveitis
Paracentesis of the anterior chamber in Paients with uveitis undergoing cataract surgery
Procedure: Paracentesis of the anterior chamber
Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.
Experimental: patients without uveitis
Paracentesis of the anterior chamber in patients without uveitis undergoing routine cataract surgery
Procedure: Paracentesis of the anterior chamber
Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare flaremetry readings with the protein content of the aqueous humor
Time Frame: one month
Compare flaremetry readings with the protein content of the aqueous and the clinical grading.
one month

Collaborators and Investigators

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

Sponsor

The Eye Center and The Eye Foundation for Research in Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEC 123
  • TEC 2012-003 (Other Identifier: THE EYE CENTER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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