Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000376943
Ethics application status
Not yet submitted
Date submitted
12/04/2011
Date registered
12/04/2011
Date last updated
12/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring Tear Flow after Tear Duct Repair
Scientific title
Measuring the outflow of tears with the drop test from the surface of the eye in patients who have undergone tear duct repair
Secondary ID [1] 259981 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mono-canalicular (tear duct) repair 265605 0
Condition category
Condition code
Eye 265752 265752 0 0
Diseases / disorders of the eye
Injuries and Accidents 265756 265756 0 0
Other injuries and accidents
Surgery 265757 265757 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study with patients recruited over 1 year. Tear drainage is measured by the drop test. Measured aliquots of saline are placed on the ocular surface avoiding overflow for 3 minutes. After this period, any excess fluid is quantified. This test is performed 4 times, without punctal plugs, with both canaliculi occluded, and with one or other canaliculus occluded, in a randomised order.
Intervention code [1] 264394 0
Not applicable
Comparator / control treatment
The unoperated fellow eye will serve as a control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266509 0
Tear drainage rate
Timepoint [1] 266509 0
Measured over 3-minute period
Secondary outcome [1] 273929 0
The level of epiphora (eye watering) experienced by participants on a daily basis since undergoing surgery will be graded on a 10 point scale
Timepoint [1] 273929 0
Symptoms as defined above will be recorded at the time of review

Eligibility
Key inclusion criteria
Surgical repair of the eyelid with canalicular silicone stenting within the last 5 years
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing dry eye or other anterior segment pathology
Significant eyelid tissue loss during trauma
Subsequent surgery on the tear drainage system (e.g DCR)
Systemic disease preventing the patient from lying flat for the duration of the test.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3379 0
New Zealand
State/province [1] 3379 0

Funding & Sponsors
Funding source category [1] 264856 0
Self funded/Unfunded
Name [1] 264856 0
University of Auckland
Country [1] 264856 0
New Zealand
Funding source category [2] 264857 0
Self funded/Unfunded
Name [2] 264857 0
Department of Ophthalmology
Country [2] 264857 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 263955 0
Hospital
Name [1] 263955 0
Auckland District Health Board
Address [1] 263955 0
Greenlane Clinical Centre
214 Greenlane West
Epsom
Auckland 1051
Country [1] 263955 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266819 0
Ethics committee address [1] 266819 0
Ethics committee country [1] 266819 0
Date submitted for ethics approval [1] 266819 0
12/04/2011
Approval date [1] 266819 0
Ethics approval number [1] 266819 0

Summary
Brief summary
When people damage their tear ducts through trauma or accident the patient may have a watery eye afterwards for the rest of their life. The doctor may decide to repair the tear duct but repairing the tear duct can be difficult and we are unsure how much function the tear ducts have after repair. We would like to measure how well the tear ducts work in patients who have undergone surgical repair. We have previously looked at healthy volunteers and have established what normal tear drainage should be, for comparison (reference in publication list below)
Trial website
Trial related presentations / publications
Murgatroyd H, Craig JP, Sloan B. Determination of relative contribution of the superior and inferior canaliculi to the lacrimal drainage system in health using the drop test. Clin Experiment Ophthalmol. 2004 Aug;32(4):404-10
Public notes

Contacts
Principal investigator
Name 32472 0
Address 32472 0
Country 32472 0
Phone 32472 0
Fax 32472 0
Email 32472 0
Contact person for public queries
Name 15719 0
Jennifer P. Craig
Address 15719 0
Department of Ophthalmology
University of Auckland
Private Bag 92019
Auckland
Country 15719 0
New Zealand
Phone 15719 0
6499238173
Fax 15719 0
Email 15719 0
jp.craig@auckland.ac.nz
Contact person for scientific queries
Name 6647 0
Jennifer P. Craig
Address 6647 0
Department of Ophthalmology
University of Auckland
Private Bag 92019
Auckland
Country 6647 0
New Zealand
Phone 6647 0
6421853664
Fax 6647 0
Email 6647 0
jp.craig@auckland.ac.nz

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.