Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

August 29, 2014 updated by: Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology
The main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 40 eyes will be included. 20 eyes with scleral inflammation and 20 eyes from healthy subjects as controls. Each patient will undergo complete ophthalmic and medical examination. Laboratory studies will performed whenever indicated. Optical coherence tomography B-scans of the sclera in the perilimbal area will done for all cases.

Study Type

Interventional

Enrollment (Actual)

32

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over the age of 18 years any gender
  • Patients with clinical signs of scleritis or episcleritis
  • Signed informed consent

Exclusion Criteria:

  • Infectious keratitis or conjunctivitis
  • Patients 18 years or younger
  • Inability to open the eye

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 clinical signs of scleritis or episcleritis
Optical Coherence Tomography for patients with scleral inflammation
Other: Optical Coherence Tomography
Experimental: Normal subjects with normal sclera
Optical Coherence Tomography on eyes with normal scleral
Other: Optical Coherence Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation
Time Frame: 3 months
To differentiate cases with anterior scleritis from those with episcleritis and normal controls
3 months

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

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

July 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 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 125
  • TEC 2013-006 [THE EYE CENTER]

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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