NCT01905579

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

July 18, 2013

Last Update Submit

August 29, 2014

Conditions

Uveitis

Keywords

flaremetryaqueous proteinsclinical gradingCompare flaremetry readings with the protein content of the aqueousCompare flaremetry readings with clinical grading of flare

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients with uveitis

EXPERIMENTAL

Paracentesis of the anterior chamber in Paients with uveitis undergoing cataract surgery

Procedure: Paracentesis of the anterior chamber

patients without uveitis

EXPERIMENTAL

Paracentesis of the anterior chamber in patients without uveitis undergoing routine cataract surgery

Procedure: Paracentesis of the anterior chamber

Interventions

Paracentesis of the anterior chamberPROCEDURE

Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.

patients with uveitispatients without uveitis

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Infectious uveitis
  • endophthalmitis
  • cases with corneal scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Eye Center

Riyadh, Saudi Arabia

Location

Related Publications (1)

  • Shoughy SS, Elkum N, Tabbara KF. Aqueous protein level and flare grading. Acta Ophthalmol. 2015 Mar;93(2):e173-4. doi: 10.1111/aos.12522. Epub 2014 Aug 31. No abstract available.

    PMID: 25175512DERIVED

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Samir S Shoughy

    THE EYE CENTER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 23, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

SA(1)