NCT01958567

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

October 7, 2013

Last Update Submit

August 29, 2014

Conditions

Scleritis and Episcleritis

Keywords

ScleritisEpiscleritisOptical coherence Tomography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients with clinical signs of scleritis or episcleritis

EXPERIMENTAL

Optical Coherence Tomography for patients with scleral inflammation

Other: Optical Coherence Tomography

Normal subjects with normal sclera

EXPERIMENTAL

Optical Coherence Tomography on eyes with normal scleral

Other: Optical Coherence Tomography

Interventions

Optical Coherence TomographyOTHER
Normal subjects with normal scleraPatients with clinical signs of scleritis or episcleritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Eye Center

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Scleritis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Scleral DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

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

October 7, 2013

First Posted

October 9, 2013

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

SA(1)