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
ACTRN12611000273987
Ethics application status
Not yet submitted
Date submitted
1/03/2011
Date registered
15/03/2011
Date last updated
13/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Estimating the lacrimal punctum size in an adult population
Query!
Scientific title
A single centre, observational, prospective study evaluating the lacrimal punctum size in an adult population
Query!
Secondary ID [1]
259702
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lacrimal Punctum Size
261276
0
Query!
Condition category
Condition code
Eye
259426
259426
0
0
Query!
Diseases / disorders of the eye
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
The aim is to investigate the variation in size of the lacrimal punctum in a normal adult population. The lacrimal puncta are the openings on the inner aspect of your eye which drains tears from the eye into the nose.
This opening is important for correct drainage of tears and abnormalities in its size can lead to problems such as watery eye, or dry eye disease.
The punctum will be observed and measured once only during one clinic visit to the hospital.
The Punctal shape and Punctal parameters including the diameter, horizontal and length and cross-sectional area will be measured and recorded
The shape of the punctum when open– which has been described as either round, oval or slit-shaped
The diameter of the punctum – measured using a Ramsden eyepiece consisting of a fixed transparent graduated scale with resolution 0.03mm positioned at the field stop fitted to the slit-lamp with magnification of the optical arrangement fixed at 32x
For oval puncta – both maximum and minimum lengths will be taken
For slit-shaped puncta – both length and breadth will be taken
The area of the punctum
Photographs of all four puncta will be taken using slit lamp biomicroscopy
A computer cursor assembly probe and digitalizer will be used to map the borders of the puncta and the area will be calculated using a photo editing computer program.
Recruitment period duration is aprroximately 1 month.
Query!
Intervention code [1]
264132
0
Not applicable
Query!
Comparator / control treatment
N/A
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
262235
0
Punctal shape
The shape of the punctum when open which has been described as either round, oval or slit-shaped.
This assessment will be made by clinical observation of the investigator.
Query!
Assessment method [1]
262235
0
Query!
Timepoint [1]
262235
0
Once only
Query!
Primary outcome [2]
262325
0
The diameter of the punctum measured using a Ramsden eyepiece consisting of a fixed transparent graduated scale with resolution 0.03mm positioned at the field stop fitted to the slit-lamp with magnification of the optical arrangement fixed at 32x
For oval puncta both maximum and minimum lengths will be taken
For slit-shaped puncta both length and breadth will be taken
Query!
Assessment method [2]
262325
0
Query!
Timepoint [2]
262325
0
Once only
Query!
Primary outcome [3]
262326
0
The area of the punctum
Photographs of all four puncta will be taken using slit lamp biomicroscopy
A computer cursor assembly probe and digitalizer will be used to map the borders of the puncta and the area will be calculated using a photo editing computer program
Query!
Assessment method [3]
262326
0
Query!
Timepoint [3]
262326
0
Once only
Query!
Secondary outcome [1]
273545
0
Nil
Query!
Assessment method [1]
273545
0
Query!
Timepoint [1]
273545
0
Nil
Query!
Eligibility
Key inclusion criteria
All adults attending the eye clinic for routine eye examinations
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Patients less than 18 years of age
Previous surgery or trauma to the orbit or eyelids involving the lacrimal system
Current or past history of chronic blepharitis, severe conjunctivitis
Patients with history of head and neck radiotherapy
Patient having systemic chemotherapy
Previous history of facial burns or chemical injury involving the eye
Patients with history of Stevens–Johnson syndrome or scleroderma
Query!
Study design
Purpose
Screening
Query!
Duration
Cross-sectional
Query!
Selection
Convenience sample
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
15/04/2011
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
264587
0
Hospital
Query!
Name [1]
264587
0
Royal Adelaide Hospital
Query!
Address [1]
264587
0
Discipline of Ophthalmology & Visual Sciences
Level 8 East Wing
North Terrace
Adelaide
SA 5000
Query!
Country [1]
264587
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Royal Adelaide Hospital
Query!
Address
Discipline of Ophthalmology & Visual Sciences
Level 8 East Wing
North Terrace
Adelaide
SA 5000
Query!
Country
Australia
Query!
Secondary sponsor category [1]
263726
0
None
Query!
Name [1]
263726
0
Query!
Address [1]
263726
0
Query!
Country [1]
263726
0
Query!
Ethics approval
Ethics application status
Not yet submitted
Query!
Ethics committee name [1]
260577
0
Research Ethics Committee
Query!
Ethics committee address [1]
260577
0
Research Ethics Committee
Hanson Institute
IMVS Building
North Terrace
Adelaide
SA 5000
Query!
Ethics committee country [1]
260577
0
Australia
Query!
Date submitted for ethics approval [1]
260577
0
01/03/2011
Query!
Approval date [1]
260577
0
Query!
Ethics approval number [1]
260577
0
Query!
Ethics committee name [2]
260578
0
Royal Adelaide Hospital Research Ethics Committee
Query!
Ethics committee address [2]
260578
0
Hanson Institute
IMVS Building
North Terrace
Adelaide
SA 5000
Query!
Ethics committee country [2]
260578
0
Query!
Date submitted for ethics approval [2]
260578
0
01/03/2011
Query!
Approval date [2]
260578
0
Query!
Ethics approval number [2]
260578
0
Query!
Summary
Brief summary
This study is been carried out to investigate the variation in size of the lacrimal punctum in a normal adult population. The lacrimal punctaare are the openings on the inner aspect of your eye which drains tears from the eye into the nose.
This opening is important for correct drainage of tears and abnormalities in its size can lead to problems such as watery eye, or dry eye disease.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32289
0
Query!
Address
32289
0
Query!
Country
32289
0
Query!
Phone
32289
0
Query!
Fax
32289
0
Query!
Email
32289
0
Query!
Contact person for public queries
Name
15536
0
Dr Weng Onn Chan
Query!
Address
15536
0
Discipline of Ophthalmology & Visual Sciences, South Australian Institute of Ophthalmology,
Level 8, East Wing
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Query!
Country
15536
0
Australia
Query!
Phone
15536
0
+61 08 8222 2729
Query!
Fax
15536
0
+61 08 8222 2741
Query!
Email
15536
0
[email protected]
Query!
Contact person for scientific queries
Name
6464
0
Dr Weng Onn Chan
Query!
Address
6464
0
Discipline of Ophthalmology & Visual Sciences, South Australian Institute of Ophthalmology,
Level 8, East Wing
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Query!
Country
6464
0
Australia
Query!
Phone
6464
0
+61 08 8222 2729
Query!
Fax
6464
0
+61 08 8222 2741
Query!
Email
6464
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