Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000411448
Ethics application status
Approved
Date submitted
2/08/2007
Date registered
13/08/2007
Date last updated
13/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of corneal thickness on intraocular pressure measurements with the Pascal dynamic contour tonometry, Canon TX-10 non-contact tonometry and Goldmann applanation tonometry in healthy subjects
Scientific title
"Effect of corneal thickness on intraocular pressure measurements with the Pascal dynamic contour tonometry, Canon TX-10 non-contact tonometry and Goldmann applanation tonometry in healthy subjects"
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraocular pressure 2215 0
Condition category
Condition code
Eye 2306 2306 0 0
Normal eye development and function
Eye 2335 2335 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We investigated the effects of central corneal thickness (CCT) on intraocular pressure (IOP) measurements of the Pascal dynamic contour tonometry (DCT), Canon TX-10 non-contact tonometry (NCT), and Goldmann applanation tonometry measurements (GAT) in healthy eyes.
The IOP measurements were taken in random order to guarantee an independent measurement of all instruments. Each measurement performed by the same physician (AP) three times consecutively with each of the three devices in the same day. The mean of these three measurement was recorded. After each measurement on each instrument a rest period of 10 min was allowed to minimize the tonographic effects of applanation tonometry. For DCT, three readings of 'good' quality were saved (score = 3 on a scale up to 5, as recommended by the manufacturer)
Subsequently, another physician (RAY) carried out ultrasonic pachymetry (UP-1000 Ultrasonic pachymeter, Nidek Co, Japan) The mean of 5 measurements was recorded for analysis.
Recent evidence has confirmed the wide variation in corneal thickness and raised the possibility that corneas that are thicker or thinner than average might be associated with clinically significant overestimates or underestimates of IOP
Intervention code [1] 1926 0
Diagnosis / Prognosis
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3201 0
All effected from cantral corneal thickness
Timepoint [1] 3201 0
At eye examination day
Primary outcome [2] 3230 0
IOP measurements with DCT seem to be less dependent on CCT
Timepoint [2] 3230 0
at baseline
Secondary outcome [1] 5341 0
IOP level
Timepoint [1] 5341 0
At examination day
Secondary outcome [2] 5389 0
DCT measurements were significantly higher than NCT and GAT measurements
Timepoint [2] 5389 0
at baseline

Eligibility
Key inclusion criteria
healthy subjects
normal eyes
normal IOP level
Minimum age
39 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, trauma, corneal abnormalities (such as edema, scars, dystrophy, astigmatism >1 dioptr) previous refractive surgery, history of ocular surgery, use of eye drops and glaucoma.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The clinican was blinded
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment outside Australia
Country [1] 556 0
Turkey
State/province [1] 556 0

Funding & Sponsors
Funding source category [1] 2472 0
University
Name [1] 2472 0
Faculty of Medicine
Ophthalmology Department
Baskent University
Country [1] 2472 0
Turkey
Funding source category [2] 2498 0
University
Name [2] 2498 0
Baskent Univ. Medical Faculty.
Country [2] 2498 0
Turkey
Primary sponsor type
University
Name
Faculty of Medicine
Address
Baskent UniversityOphthalmology Department. Yuregir/
Country
Turkey
Secondary sponsor category [1] 2271 0
Hospital
Name [1] 2271 0
Baskent Univ.Hospital
Address [1] 2271 0
Dadaloglu Mh
Country [1] 2271 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4349 0
Baskent University Faculty of Medicine ethics committee
Ethics committee address [1] 4349 0
Ethics committee country [1] 4349 0
Turkey
Date submitted for ethics approval [1] 4349 0
Approval date [1] 4349 0
Ethics approval number [1] 4349 0
KA05/207

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27740 0
Address 27740 0
Country 27740 0
Phone 27740 0
Fax 27740 0
Email 27740 0
Contact person for public queries
Name 11115 0
Aysel Pelit
Address 11115 0
Baskent University
Faculty of Medicine
Ophthalmology Depart
Yuregir Adana
Country 11115 0
Turkey
Phone 11115 0
+903272727
Fax 11115 0
Email 11115 0
aypelit@yahoo.com
Contact person for scientific queries
Name 2043 0
Aysel Pelit
Address 2043 0
Baskent University
Faculty of Medicine
Ophthalmology Depart
Yuregir Adana
Country 2043 0
Turkey
Phone 2043 0
+903272727
Fax 2043 0
Email 2043 0
aypelit@yahoo.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.