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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905579
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology

Brief 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.

Condition or disease Intervention/treatment Phase
Uveitis Procedure: Paracentesis of the anterior chamber Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905579


Locations
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Saudi Arabia
The Eye Center
Riyadh, Saudi Arabia
Sponsors and Collaborators
The Eye Center and The Eye Foundation for Research in Ophthalmology
Investigators
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Principal Investigator: Samir S Shoughy THE EYE CENTER
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samir S. Shoughy, MD, FRCS (Glasg.), Ophthalmologist, The Eye Center and The Eye Foundation for Research in Ophthalmology
ClinicalTrials.gov Identifier: NCT01905579    
Other Study ID Numbers: TEC 123
TEC 2012-003 ( Other Identifier: THE EYE CENTER )
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology:
flaremetry
aqueous proteins
clinical grading
Compare flaremetry readings with the protein content of the aqueous
Compare flaremetry readings with clinical grading of flare
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases