Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

Scleritis and Episcleritis Clinical Trial

Official title:

Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958567
• Other study ID #: TEC 125
• Secondary ID: TEC 2013-006 [TH
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: August 29, 2014
• Start date: July 2012
• Est. completion date: April 2014

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Scleritis
• Scleritis and Episcleritis

Intervention

Other:
• Optical Coherence Tomography

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	To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation	To differentiate cases with anterior scleritis from those with episcleritis and normal controls	3 months	No