Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001659493
Ethics application status
Approved
Date submitted
30/10/2016
Date registered
1/12/2016
Date last updated
1/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ocular Surface Parameters in Celiac Disease
Scientific title
Local Ocular Surface Parameters in Patients with Systemic Celiac Disease
Secondary ID [1] 290414 0
Nil Known
Universal Trial Number (UTN)
U1111-1189-2363
Trial acronym
Celiac Disease
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 300754 0
Condition category
Condition code
Inflammatory and Immune System 300588 300588 0 0
Autoimmune diseases
Eye 300826 300826 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Schirmer test, tear film break-up time evaluation, and conjunctival impression cytology will performe in addition to a complete ophthalmologic examination. Single assessment session is performed.
The Schirmer's test was performed using a standardized kit containing a strip of filter paper 5×30-mm2 and placed on to the lower lid margin in a temporal position. The patient looked up and blinked normally for 5 minute before the strip was removed and the length of wetted paper measured. A value of <5 mm was taken as abnormal.
The stability of the tear film over the conjunctiva and cornea was assessed using a Burton's lamp with a cobalt blue filter and sodium fluorescein. A drop of 2% sodium fluorescein was applied to the eye, and the patient was asked to blink five times so that a film is formed over the cornea and bulbar conjunctiva. The patient was then asked to refrain from blinking during which time black spots or lines begin to appear indicating dry spots. The interval (second) between the last blink and the first randomly distributed dry spot was taken as the tear break-up time. An average of three measurements was recorded. A value of <10 second was taken as abnormal.
Impression cytology of the conjunctiva of the topically anaesthetized eye was performed according to the technique described by Nelson et al. Small disks of cellulose acetate filter paper (MFS, Advantec MFS, Pleasanton, USA, pore size 0.2 micrometer) were cut into pieces approximately 4×5-mm2 in size, placed on the superior nasal interpalpebral conjunctiva 5 mm from the limbus, gently pressed for 5 second, and then removed. The specimens were placed in a fixative solution and stained with Papanicolau's modification of Gill's technique.
Single assessment session is performed in one hour.
Intervention code [1] 296248 0
Not applicable
Comparator / control treatment
25 healthy adult subjects serving as controls with no history of systemic or ocular disease. The Schirmer test, tear film break-up time evaluation, and conjunctival impression cytology will performe in these participants.
Control group
Active

Outcomes
Primary outcome [1] 300007 0
Rate of tear production assessed using the Schirmer test
Timepoint [1] 300007 0
1 month post enrolment.
Primary outcome [2] 300008 0
Stable and healthy tear film assessed using the Tear film break-up time
Timepoint [2] 300008 0
1 month post enrolment.
Primary outcome [3] 300009 0
Epithelial cell morphology, cytoplasmic and nuclear characteristics and quantify the goblet cell population in the conjunctiva assessed using the Conjunctival impression cytology. This is a composite secondary outcome.
Timepoint [3] 300009 0
1 month post enrolment.
Secondary outcome [1] 328798 0
None
Timepoint [1] 328798 0
None

Eligibility
Key inclusion criteria
We will include the Celiac Disease patients. The diagnosis of Celiac Disease will reached according to the ESPGHAN criteria that had no vitamin deficiency and were using a gluten free diet. Patients and healthy volunteers that are matched for age and gender will include in this study
Minimum age
22 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients and healthy volunteers who were on any kind of medication including corticosteroid and immunosuppressive therapy, who had smoking (smoke more than 1 cigarette per day) and drinking ( >1 standard drink per week) habits, or who had history of systemic and ocular disease will not included in the study

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/11/2016
Date of last participant enrolment
Anticipated
30/12/2016
Actual
Date of last data collection
Anticipated
30/12/2016
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 8357 0
Turkey
State/province [1] 8357 0
Turkey

Funding & Sponsors
Funding source category [1] 294821 0
Hospital
Name [1] 294821 0
Ankara Ulucanlar Eye Education and research hospital.
Country [1] 294821 0
Turkey
Primary sponsor type
Hospital
Name
SB Ankara Ulucanlar Eye Education and Research Hospital
Country
Turkey
Secondary sponsor category [1] 293666 0
None
Name [1] 293666 0
None
Country [1] 293666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296212 0
Ankara Numune Training and Research Hospital
Ethics committee address [1] 296212 0
Ethics committee country [1] 296212 0
Turkey
Date submitted for ethics approval [1] 296212 0
01/10/2014
Approval date [1] 296212 0
15/10/2014
Ethics approval number [1] 296212 0
15811

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 70010 0
Prof Mehmet CITIRIK
Address 70010 0
SB Ankara Ulucanlar Eye Education and Research Hospital. Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 70010 0
Turkey
Phone 70010 0
+903123126261
Fax 70010 0
+903123124827
Email 70010 0
mcitirik@hotmail.com
Contact person for public queries
Name 70011 0
Murat Uzel
Address 70011 0
SB Ankara Ulucanlar Eye Education and Research Hospital. Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 70011 0
Turkey
Phone 70011 0
+903123126261
Fax 70011 0
+903123124827
Email 70011 0
muzel@gmail.com
Contact person for scientific queries
Name 70012 0
Mehmet CITIRIK
Address 70012 0
SB Ankara Ulucanlar Eye Education and Research Hospital. Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 70012 0
Turkey
Phone 70012 0
+903123126261
Fax 70012 0
+903123124827
Email 70012 0
mcitirik@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.