Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000565549p
Ethics application status
Not yet submitted
Date submitted
21/01/2024
Date registered
5/05/2024
Date last updated
5/05/2024
Date data sharing statement initially provided
5/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Effectiveness of a Novel Contact Lens (Ortho C) on Paediatric Nearsightedness and Mood
Scientific title
Effect of an Ortho C contact lens on visual acuity and mood in Paediatric Patients with Myopia
Secondary ID [1] 311136 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myopia 332303 0
negative mood
 332306 0
Condition category
Condition code
Eye 329015 329015 0 0
Diseases / disorders of the eye
Mental Health 329016 329016 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is based on a rigid contact lens without any prescription. The treatment is named orthokeratology (or ortho C) to differentiate it from an existing contact lens treatment on the market known as ortho K. An ortho C lens is designed according to the participant's cornea curvature. A cornea curvature measurement called a k reading (or keratometer reading) will be taken prior to fitting an ortho C lens.

The curvature of the cornea is different on every eye. The cornea curvature of the right eye is usually different from the left eye, and the cornea curvature of one participant is different from another. It is necessary to take a cornea curvature measurement call a k reading (or keratometer reading) prior to fitting a generic or ortho C lens. This will be performed using an autorefractor, and it takes approximately 5 minutes. The participant's forehead is placed against a headrest at the front and the chin is rested on a chinrest at the bottom. The participant would look at an image on a computer screen. I will operate the autorefractor to take the horizontal and vertical curvature of the cornea of each eye.

I will design the lens based on the above information. The lens is slightly flatter than the average curvature of the cornea. The average curvature is the average between the horizontal and vertical cornea readings taken with the autorefractor. The measurements are expressed in diopters. The flatness of the lens is according to the absolute value of the prescription of the eye. If the prescription is -0.50 D, the curvature of the lens is 0.50 D flatter. If it is -0.75 D, the curvature of the lens is 0.75 D flatter, etc. The maximum flatness is 2.0 D. The diameter of the lens is generally 9.2 mm. There is no prescription. It is a plain lens. The thickness is 0.15 mm. It is within the specification of Stein, Slatt, Stein, and Freeman (2002). The specifications for the curvature of the lens varies for each individual. The specifications for the power and the thickness is fixed. The lens is a rigid gas permeable lens. The material is made by Bausch and Lomb. The type of material is Boston EO. The above parameters of a lens for each participant is sent to an optical lab in Toronto: Optik K and R.

The time it takes to design the lens is about 15 minutes. The time it takes to manufacture the lens is about a week. It is designed to last for a life time. But the participant will not need to wear the lenses after 1 or 2 years.

The following steps 1 to 4 are performed first before applying the intervention:
1. Perform a visual acuity test to establish benchmark.
2. Have the participant complete the following assessments: Mood Assessment Sheet, the Hare Self-Esteem assessment, and the Kidscreen Quality of Life assessment.
3. Measure the participant's cornea curvature.
4. Design the lens according to the cornea curvature.

The following steps of the intervention consists of the Distant Drill and the Snellen chart drill. The following steps 5 to 7 are performed after receiving the lens from the lab:
5. One lens is worn on the better eye first. The participant will perform the Distant Drill first by looking at a distant object outdoors at approximately 300 feet for 30 seconds. The other eye is covered. The lens is then removed. The participant will then perform the Snellen chart drill by reading the 20/25 line on a Snellen chart (which is calibrated for 10 feet) for five times at 5 feet away. The procedure is repeated on the other eye.
6. Take another visual acuity test and compare it to the benchmark reading taken in step 1 to determine the improvement in visual acuity. This is done at the end of every follow-up period.
7, During the last follow-up, have the participant complete again the Mood Assessment Sheet, the Hare Self-Esteem assessment, and the Kidscreen Quality of Life assessment.

The participant will wear the lens on one eye at a time. It is worn just once to perform the intervention on the first day of each follow-up period. I will insert the lens onto children when they come to see me. I will teach adolescents how to insert and remove the lens with a contact lens remover. I will teach them how to keep the lens clean to avoid eye infection.
The wearing duration of each lens (how long the lens is on the cornea before it is removed) is about 1 minute.

I will supervise the drill the participant will perform with the lens on to ensure it is according to protocol. I will instruct the participant on how to avoid near-point stress. They will not wear a minus lens which is designed for the distance for near work. When engaging in prolonged near work, they will follow the 20/20 rule: look away every 20 minutes to focus on an object beyond 20 feet for 20 seconds.

The wearing frequence (how often to wear the lens) is once a week (for 4 visits) and then once every 2 weeks (for 3 visits).
The following are the scheduled follow-up periods:
The first interval is 1 week apart. We would meet 4 times (once per week).
The next interval is 2 weeks apart. We would meet 3 times (once every two weeks.

The wearing duration (how long the lens is on the cornea) is about a minute. The duration is made up of the following:
The time it takes to position oneself 3 feet from the window and look at the object of regard 300 feet away.
The time it takes to perform the intervention.
The time it takes to position oneself in front of a mirror to remove the lens with a contact lens remover.

Delivering the Intervention
Study procedures will be completed by an optician.
Intervention code [1] 327584 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336993 0
Visual acuity
Timepoint [1] 336993 0
A visual acuity test is conducted at the end of every week during the first 4 weeks and at the end of every second week for the next 3 weeks.
Secondary outcome [1] 430338 0
Mood
Timepoint [1] 430338 0
The participant’s Mood Assessment Sheet is reviewed at the end of every week during the first 4 follow-ups and at the end of every second week for the next 3 follow-ups.
Secondary outcome [2] 432899 0
Self-Esteem
Timepoint [2] 432899 0
Baseline and at the end of the follow-up periods (at the end of 10 weeks).
Secondary outcome [3] 432900 0
Quality of Life
Timepoint [3] 432900 0
Baseline and at the end of the follow-up periods (at the end of 10 weeks).

Eligibility
Key inclusion criteria
Include participants 6 to 16 years of age with myopia.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
Date of last participant enrolment
Anticipated
1/02/2027
Actual
Date of last data collection
Anticipated
13/04/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26058 0
Canada
State/province [1] 26058 0
Ontario

Funding & Sponsors
Funding source category [1] 315393 0
Government body
Name [1] 315393 0
Canadian Institutes of Health Research
Country [1] 315393 0
Canada
Primary sponsor type
University
Name
University of Waterloo
Address
200 University Avenue West, Waterloo, Ontario N2L 3G1
Country
Canada
Secondary sponsor category [1] 317456 0
None
Name [1] 317456 0
Address [1] 317456 0
Country [1] 317456 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314310 0
Office of Research, University of Waterloo, East Campus, 3rd Floor, 200 University Avenue West, Waterloo, Ontario, Canada N2L 3G1
Ethics committee address [1] 314310 0
Ethics committee country [1] 314310 0
Canada
Date submitted for ethics approval [1] 314310 0
06/05/2024
Approval date [1] 314310 0
Ethics approval number [1] 314310 0

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

Contacts
Principal investigator
Name 131142 0
Dr John William Yee
Address 131142 0
University of Waterloo, 200 University Avenue West, Waterloo, Ontario N2L 3G1
Country 131142 0
Canada
Phone 131142 0
+16473932228
Fax 131142 0
Email 131142 0
[email protected]
Contact person for public queries
Name 131143 0
John William Yee
Address 131143 0
University of Waterloo, 200 University Avenue West, Waterloo, Ontario N2L 3G1
Country 131143 0
Canada
Phone 131143 0
+16473932228
Fax 131143 0
Email 131143 0
[email protected]
Contact person for scientific queries
Name 131144 0
John William Yee
Address 131144 0
University of Waterloo, 200 University Avenue West, Waterloo, Ontario N2L 3G1
Country 131144 0
Canada
Phone 131144 0
+16473932228
Fax 131144 0
Email 131144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after de-identification.
When will data be available (start and end dates)?
Immediately following publication and available for 5 years after publication.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Subject to approvals by Principal Investigator: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21306Study protocol  [email protected]
21307Informed consent form  [email protected]
21308Clinical study report  [email protected]
21309Ethical approval  [email protected]



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.