Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001532291
Ethics application status
Approved
Date submitted
10/09/2018
Date registered
13/09/2018
Date last updated
13/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of short-term imposed optical defocus on central and peripheral eye length
and choroidal thickness in healthy subjects.
Scientific title
Effects of short-term imposed optical defocus on central and peripheral eye length
and choroidal thickness in healthy subjects.
Secondary ID [1] 296044 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eye length 309598 0
Choroidal thickness 309599 0
Condition category
Condition code
Eye 308415 308415 0 0
Normal eye development and function
Eye 308416 308416 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be prospective.
Participants will wear two contact lens designs for 30 minutes, with a minimum 4 hours washout between lens types. One lens type is designed to correct myopia and hyperopia, while the other one is designed to correct presbyopia. The materials and parameters for each lens type are:
single vision lens: etafilcon A, base curve = 8.5 mm, diameter = 14.2 mm, with power of +3.00D, -3.00D for 1day AcuvueMoist;
multifocal lens: omafilcon, base curve = 8.7 mm, diameter = 14.4 mm, with power 0.00D /Add +2.50D.
The minimum wearing time will be 30 minutes per visit with no maximum wearing time provided.
After preliminary evaluation, three to five visits will be require for the study. The first three visits will be compulsory for every participant and will include wearing + 300D, -3.00D and the multifocal lens at visit 1, visit 2 and visit 3, respectively. The total number of visits will be determined based on the results (e.g. degree of refractive error, time of measurement, etc.) from the compulsory visits. The time between the visits will be from 4 hours to 30 days. The preliminary visit will be approximately 45 minutes in duration and will include auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye). Each visit will be approximately 1h45 min each in duration and will include three sessions (of 15 minutes each):
Session 1: Baseline measurement
Session 2: Baseline measurement and contact lens fitting
Session 3: Assessment measurement (taken after 30 min soon after removing the contact lens)
The time interval between each session is 30 minutes. At the end of the second session, there will be a contact lens fitting followed by an assessment of contact lenses on the eye with a slit-lamp biomicroscope (a specialized microscope for viewing the eye). Between the second and third set of measurements, the participant will be required to wear the contact lens in one eye and will wear their normal prescription lens (on a trial frame) in the other eye and watch a video on a distant monitor for 30 minutes. The contact lens will be removed before the last set of measurements. All contact lenses will be provided and all assessments will be carried out by an optometrist.
Intervention code [1] 312383 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Active

Outcomes
Primary outcome [1] 307381 0
eye length
The measurement will be done using the Lenstar LS 900.
Timepoint [1] 307381 0
Session 1: Baseline measurement
Session 2: Baseline measurement and contact lens fitting
Session 3: Assessment measurement (taken after 30 min soon after removing the contact lens)
Primary outcome [2] 307382 0
choroidal thickness
The measurement will be done using the Triton DRI OCT.
Timepoint [2] 307382 0
Session 1: Baseline measurement
Session 2: Baseline measurement and contact lens fitting
Session 3: Assessment measurement (taken after 30 min soon after removing the contact lens)
Secondary outcome [1] 351727 0
Accommodative response
The measurement will be done using the Grand Seiko WAM5500.
Timepoint [1] 351727 0
Session 1: Baseline measurement
Session 2: Baseline measurement and contact lens fitting
Session 3: Assessment measurement (taken after 30 min soon after removing the contact lens)

Eligibility
Key inclusion criteria
Inclusion criteria:
• Any gender;
• Aged more than 18 years;
• Participant to provide informed consent;
• Either has a refractive error of the eye (a condition that causes blur for either distance or near) or no refractive error
• Have ocular health findings considered to be “normal” and no anterior segment or posterior segment condition other than refractive error;
• Have best corrected visual acuity to at least 6/6 or better in each eye with spectacles or contact lenses;
• No history of amblyopia or strabismus;
• Can be an experienced soft contact lens wearer or a neophyte (no previous experience contact lens wearer);
• No history of rigid contact lens wear;
• Being able to read and communicate in English;
• Be willing to comply with clinical trial visit schedule as directed by the investigator.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
• Age < 18 years;
• History of any systemic diseases including diabetes, hypertension, cardiac problems etc.;
• History of any other ocular pathology;
• History of any refractive or ocular surgeries;
• History of using orthokeratology lenses.

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
24/09/2018
Actual
Date of last participant enrolment
Anticipated
28/02/2019
Actual
Date of last data collection
Anticipated
30/03/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300633 0
Other Collaborative groups
Name [1] 300633 0
Brien Holden Vision Institute
Country [1] 300633 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brien Holden Vision Institute
Address
Level 4, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 300145 0
None
Name [1] 300145 0
none
Address [1] 300145 0
Country [1] 300145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301422 0
The Univversity of New South Wales Human Research Ethics Committee
Ethics committee address [1] 301422 0
UNSW Research Ethics & Compliance Support

The University of New South Wales

Sydney NSW 2052 Australia
Ethics committee country [1] 301422 0
Australia
Date submitted for ethics approval [1] 301422 0
02/03/2018
Approval date [1] 301422 0
24/04/2018
Ethics approval number [1] 301422 0
HC 180120

Summary
Brief summary
The purpose of the study is to investigate the effects of short-term imposed blur (optical defocus) on central and peripheral length and the vascular layer of the eye ( choroid) that may help to predict that an optical intervention can control myopia progression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67834 0
Dr Klaus Ehrmann
Address 67834 0
Brien Holden Vision Institute,
Level 4, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 67834 0
Australia
Phone 67834 0
+61 2 9385 7495
Fax 67834 0
Email 67834 0
[email protected]
Contact person for public queries
Name 67835 0
Klaus Ehrmann
Address 67835 0
Brien Holden Vision Institute,
Level 4, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 67835 0
Australia
Phone 67835 0
+61 2 9385 7495
Fax 67835 0
Email 67835 0
[email protected]
Contact person for scientific queries
Name 67836 0
Klaus Ehrmann
Address 67836 0
Brien Holden Vision Institute,
Level 4, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 67836 0
Australia
Phone 67836 0
+61 2 9385 7495
Fax 67836 0
Email 67836 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

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