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Trial registered on ANZCTR


Registration number
ACTRN12610000206022
Ethics application status
Not yet submitted
Date submitted
3/03/2010
Date registered
11/03/2010
Date last updated
25/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The Acceptability of an Alternative Contact Lens Treatment for People with Keratoconus.
Scientific title
Investigation of the Satisfaction and Acceptability of the SynergEyes (trademark) Hybrid Contact Lens for Keratoconic Corneas in New Zealand.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keratoconus 256942 0
Condition category
Condition code
Eye 257084 257084 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Third generation hybrid contact lens. They are to be worn by study participants full time, for at least 8 hours during the daytime and removed before sleeping, for a total of 6 weeks.
Intervention code [1] 256103 0
Treatment: Devices
Comparator / control treatment
Rigid Gas Permeable (RGP) contact lens. These lenses have been previously worn by the study participants as their current mode of ocular correction. They are worn daily and removed before bedtime. Subjects are to have worn these lenses for at least 8 hours a day for a total of 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 257943 0
Comfort. This will be assessed by questionnaires filled out by the study participant with help from a study investigator to answer any queries. This questionnaire has been specifically written for this study including some questions adapted from the The Contact Lens Impact on Quality of Life and the National Eye Institute Visual Functioning Questionnaire 2000.
Timepoint [1] 257943 0
At 2 and 6 weeks after intervention commencement.
Primary outcome [2] 257944 0
Contact lens complications. This will be assessed using a non-invasive microscopy technique (slit lamp biomicroscopy). This will include temporarily staining the cornea with a harmless coloured dye (sodium fluorescein) to assess the corneal health. Contact lens complications will be graded with the Efron Grading scales.
Corneal thickness will be measured using an ultrasonic pachymeter which uses a probe that gently contacts the centre of the cornea. As it is a contact procedure, a short acting topical anaesthetic eye drop (benoxinate hydrochloride 0.4%) will be instilled.
Timepoint [2] 257944 0
At 2 and 6 weeks after intervention commencement
Primary outcome [3] 257945 0
Visual acuity. This will be measured at high contrast with a Snellen letter chart and low contrast with a Bailey-Lovie reduced contrast chart.
Timepoint [3] 257945 0
At 2 and 6 weeks after intervention commencement.
Secondary outcome [1] 263472 0
Ease of fitting. The ease of fitting will be assessed by comparing how many diagnostic lenses were ordered and trialled until a suitable fit of the lenses was achieved. The fitting of the lens is assessed by the positioning, coverage, movement, size and surface quality of the lens, and the dye (sodium fluorescein) pattern underneath the lens.
Timepoint [1] 263472 0
At the initial fitting of the SynergEyes (trademark) contact lens.

Eligibility
Key inclusion criteria
1) All subjects over 16 years of age, previously diagnosed with keratoconus in both eyes.
2) Keratoconic subjects who are prepared to try SynergEyes (trademark) hybrid contact lenses as a form of visual correction.
3) Keratoconic subjects who have worn RGP contact lenses for at least 8 hours a day for at least 6 weeks before commencing this study.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Subjects with corneal dystrophies/disease other than keratoconus
2) Normal subjects who do not have keratoconus

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 2531 0
New Zealand
State/province [1] 2531 0

Funding & Sponsors
Funding source category [1] 256594 0
University
Name [1] 256594 0
The University of Auckland
Country [1] 256594 0
New Zealand
Funding source category [2] 256595 0
Government body
Name [2] 256595 0
Ministry of Health
Country [2] 256595 0
New Zealand
Funding source category [3] 256596 0
Other
Name [3] 256596 0
Mortimer Hirst Optometrist
Country [3] 256596 0
New Zealand
Primary sponsor type
Individual
Name
Mr Grant Watters
Address
Dept of Optometry and Vision Science
University of Auckland
Private Bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 255890 0
University
Name [1] 255890 0
The University of Auckland
Address [1] 255890 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 255890 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258625 0
Ethics committee address [1] 258625 0
Ethics committee country [1] 258625 0
New Zealand
Date submitted for ethics approval [1] 258625 0
26/03/2010
Approval date [1] 258625 0
Ethics approval number [1] 258625 0

Summary
Brief summary
This study will investigate satisfaction with SynergEyes (trademark) hybrid contact lenses and gather information to design and power a larger study to investigate clinical effects. We will measure and assess the ease of fit, comfort and vision, as well as monitoring changes in eye health throughout the project. This will give an indication of the success of fitting SynergEyes (trademark) hybrid lenses in comparison to RGPs. We will also monitor any adverse side effects from SynergEyes (trademark) hybrid lenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30894 0
Address 30894 0
Country 30894 0
Phone 30894 0
Fax 30894 0
Email 30894 0
Contact person for public queries
Name 14141 0
Mr Grant Watters
Address 14141 0
Dept of Optometry and Vision Science
University of Auckland
Private Bag 92019
Auckland
Country 14141 0
New Zealand
Phone 14141 0
+64 9 3737527
Fax 14141 0
Email 14141 0
[email protected]
Contact person for scientific queries
Name 5069 0
Mr Grant Watters
Address 5069 0
Dept of Optometry and Vision Science
University of Auckland
Private Bag 92019
Auckland
Country 5069 0
New Zealand
Phone 5069 0
+64 9 3737527
Fax 5069 0
Email 5069 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.