Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
Scientific title
Local Ocular Surface Parameters in Patients with Systemic Celiac Disease
Query!
Secondary ID [1]
290414
0
Nil Known
Query!
Universal Trial Number (UTN)
U1111-1189-2363
Query!
Trial acronym
Celiac Disease
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Celiac Disease
300754
0
Query!
Condition category
Condition code
Inflammatory and Immune System
300588
300588
0
0
Query!
Autoimmune diseases
Query!
Eye
300826
300826
0
0
Query!
Diseases / disorders of the eye
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
296248
0
Not applicable
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
300007
0
Rate of tear production assessed using the Schirmer test
Query!
Assessment method [1]
300007
0
Query!
Timepoint [1]
300007
0
1 month post enrolment.
Query!
Primary outcome [2]
300008
0
Stable and healthy tear film assessed using the Tear film break-up time
Query!
Assessment method [2]
300008
0
Query!
Timepoint [2]
300008
0
1 month post enrolment.
Query!
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.
Query!
Assessment method [3]
300009
0
Query!
Timepoint [3]
300009
0
1 month post enrolment.
Query!
Secondary outcome [1]
328798
0
None
Query!
Assessment method [1]
328798
0
Query!
Timepoint [1]
328798
0
None
Query!
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
Query!
Minimum age
22
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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
Query!
Study design
Purpose
Query!
Duration
Cross-sectional
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/11/2016
Query!
Date of last participant enrolment
Anticipated
30/12/2016
Query!
Actual
Query!
Date of last data collection
Anticipated
30/12/2016
Query!
Actual
Query!
Sample size
Target
50
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
8357
0
Turkey
Query!
State/province [1]
8357
0
Turkey
Query!
Funding & Sponsors
Funding source category [1]
294821
0
Hospital
Query!
Name [1]
294821
0
Ankara Ulucanlar Eye Education and research hospital.
Query!
Address [1]
294821
0
Ulucanlar cd. no:59 06230 Altindag/Ankara/Turkey
Query!
Country [1]
294821
0
Turkey
Query!
Primary sponsor type
Hospital
Query!
Name
SB Ankara Ulucanlar Eye Education and Research Hospital
Query!
Address
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Query!
Country
Turkey
Query!
Secondary sponsor category [1]
293666
0
None
Query!
Name [1]
293666
0
None
Query!
Address [1]
293666
0
None
Query!
Country [1]
293666
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
296212
0
Ankara Numune Training and Research Hospital
Query!
Ethics committee address [1]
296212
0
Hacettepe, Talatpasa Blv No:44, 06230 Altindag/Ankara
Query!
Ethics committee country [1]
296212
0
Turkey
Query!
Date submitted for ethics approval [1]
296212
0
01/10/2014
Query!
Approval date [1]
296212
0
15/10/2014
Query!
Ethics approval number [1]
296212
0
15811
Query!
Summary
Brief summary
Purpose: To investigate the local ocular surface parameters in patients with celiac disease in comparison to those in healthy adults as controls. Design: A prospective case control study Participants and Controls: Twenty-five patients with celiac disease and 25 age-and sex-matched healthy controls will included into the study Methods: All patients and control subjects will undergo the Schirmer test, tear film break-up time, and conjunctival impression cytology in addition to a complete ophthalmological examination Main Outcome Measures: Alterations in Schirmer test, tear film break-up time, and conjunctival impression cytology. Results: The mean level of Schirmer test value in two Groups will be determined. Mean serum level of tear film break-up time in 2 groups will determined. conjunctival impression cytology garding value in two groups will determined. These parameters can be significantly altered in celiac disease patients. Conclusion: Tear film functions and conjunctival surface epithelial morphology may be significantly altered in patients with CD. The results may be important for the clinical management of patients with celiac disease.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
70010
0
Prof Mehmet CITIRIK
Query!
Address
70010
0
SB Ankara Ulucanlar Eye Education and Research Hospital. Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Query!
Country
70010
0
Turkey
Query!
Phone
70010
0
+903123126261
Query!
Fax
70010
0
+903123124827
Query!
Email
70010
0
[email protected]
Query!
Contact person for public queries
Name
70011
0
Murat Uzel
Query!
Address
70011
0
SB Ankara Ulucanlar Eye Education and Research Hospital. Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Query!
Country
70011
0
Turkey
Query!
Phone
70011
0
+903123126261
Query!
Fax
70011
0
+903123124827
Query!
Email
70011
0
[email protected]
Query!
Contact person for scientific queries
Name
70012
0
Mehmet CITIRIK
Query!
Address
70012
0
SB Ankara Ulucanlar Eye Education and Research Hospital. Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Query!
Country
70012
0
Turkey
Query!
Phone
70012
0
+903123126261
Query!
Fax
70012
0
+903123124827
Query!
Email
70012
0
[email protected]
Query!
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.
Download to PDF