Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
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
Scientific title
A single centre, observational, prospective study evaluating the lacrimal punctum size in an adult population
Secondary ID [1] 259702 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lacrimal Punctum Size 261276 0
Condition category
Condition code
Eye 259426 259426 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 264132 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

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.
Timepoint [1] 262235 0
Once only
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
Timepoint [2] 262325 0
Once only
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
Timepoint [3] 262326 0
Once only
Secondary outcome [1] 273545 0
Nil
Timepoint [1] 273545 0
Nil

Eligibility
Key inclusion criteria
All adults attending the eye clinic for routine eye examinations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264587 0
Hospital
Name [1] 264587 0
Royal Adelaide Hospital
Country [1] 264587 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Discipline of Ophthalmology & Visual Sciences
Level 8 East Wing
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 263726 0
None
Name [1] 263726 0
Address [1] 263726 0
Country [1] 263726 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260577 0
Research Ethics Committee
Ethics committee address [1] 260577 0
Ethics committee country [1] 260577 0
Australia
Date submitted for ethics approval [1] 260577 0
01/03/2011
Approval date [1] 260577 0
Ethics approval number [1] 260577 0
Ethics committee name [2] 260578 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 260578 0
Ethics committee country [2] 260578 0
Date submitted for ethics approval [2] 260578 0
01/03/2011
Approval date [2] 260578 0
Ethics approval number [2] 260578 0

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

Contacts
Principal investigator
Name 32289 0
Address 32289 0
Country 32289 0
Phone 32289 0
Fax 32289 0
Email 32289 0
Contact person for public queries
Name 15536 0
Dr Weng Onn Chan
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
Country 15536 0
Australia
Phone 15536 0
+61 08 8222 2729
Fax 15536 0
+61 08 8222 2741
Email 15536 0
[email protected]
Contact person for scientific queries
Name 6464 0
Dr Weng Onn Chan
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
Country 6464 0
Australia
Phone 6464 0
+61 08 8222 2729
Fax 6464 0
+61 08 8222 2741
Email 6464 0
[email protected]

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.