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

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905579
• Other study ID #: TEC 123
• Secondary ID: TEC 2012-003
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: August 29, 2014
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2014
• Source: The Eye Center and The Eye Foundation for Research in Ophthalmology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Uveitis

Intervention

Procedure:
• Paracentesis of the anterior chamber
Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.

Locations

Country	Name	City	State
Saudi Arabia	The Eye Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Center and The Eye Foundation for Research in Ophthalmology

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare flaremetry readings with the protein content of the aqueous humor	Compare flaremetry readings with the protein content of the aqueous and the clinical grading.	one month	No