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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


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