Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001374752
Ethics application status
Approved
Date submitted
21/10/2022
Date registered
26/10/2022
Date last updated
26/10/2022
Date data sharing statement initially provided
26/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of 0.05% atropine eye drops on the eye-related functions among adult myopes.
Scientific title
Characteristic Changes of Visual Function using Atropine Eye Drops in Adult Myopes.
Secondary ID [1] 308125 0
"Nill Know"
Universal Trial Number (UTN)
U1111-1283-6322
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressive Mypoia 327837 0
Condition category
Condition code
Eye 324913 324913 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 0.05% atropine sulfate eye drops, taken just once, as one drop in one eye. The study measurements will be taken after 30 minutes of eye drop instillation. This visit will take approximately 1 hour.

The study's investigators will only install the eye drop during the study visit, so no adherence measurements are required.

All procedures including drop instillation will be conducted at the School of Optometry and Vision Science, UNSW, and be administered by a Ph.D. candidate under the supervision of Australian registered optometrists.”
Intervention code [1] 324582 0
Treatment: Drugs
Comparator / control treatment
Each participant will serve as their own control, as the same measurements will be taken before and after the intervention.
Control group
Active

Outcomes
Primary outcome [1] 332726 0
Changes in colour contrast sensitivity functions. Measurements of the right eye will be captured using a custom computer-based program in MATLAB.
Timepoint [1] 332726 0
Visit 2: 30 minutes after the treatment has been administered.
Primary outcome [2] 332727 0
Changes in contrast sensitivity functions. Measurements of the right eye will be captured using a custom computer-based program in MATLAB.
Timepoint [2] 332727 0
Visit 2: 30 minutes after the treatment has been administered.
Primary outcome [3] 332728 0
Changes in detect motion sensitivity functions. Measurements of the right eye will be captured using a custom computer-based program in MATLAB.
Timepoint [3] 332728 0
Visit 2: 30 minutes after the treatment has been administered.
Secondary outcome [1] 414533 0
Mean changes in peripheral refractive errors measured by Autorefractor (NVision K-5001; Shin-Nippon, Tokyo, Japan). Measurements of the right eye will be captured at the center, nasal (10,20,30 degrees), and temporal ( 10, 20, 30 degrees).
Timepoint [1] 414533 0
Visit 2: 30 minutes after the treatment has been administered.
Secondary outcome [2] 414534 0
Changes in pupil size before and after the intervention measured by Neuroptics PLR-3000 pupilometer for both eyes.
Timepoint [2] 414534 0
Visit 2: before and 30 minutes after the treatment has been administered.
Secondary outcome [3] 414541 0
The optical quality of the ocular surface. Measurements of the right eye will be captured using Topcon KR-1W.
Timepoint [3] 414541 0
Visit 2: 30 minutes after the treatment has been administered.

Eligibility
Key inclusion criteria
•Aged between 18-35 years .
•Have normal general and eye health.
•Have an optical prescription between -0.50 and -4.00D; with less than -1.50D of astigmatism.
•Have ‘normal’ vision, measuring 6/7.5 or better with correction (0,2 LogMar).
•Have a normal color vision.
•Have normal intraocular pressure (IOP).
•Willing to attend two study visits.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Have used an atropine eye drop within 2 weeks prior to study enrolment.
•Have any eye diseases including inflammation, infection, or allergy.
•Have a history of allergic reactions to eye medications.
•Are at risk of glaucoma.
•Are currently using any eye medications or antidepression.
•Women who are pregnant, planning to become pregnant, or breastfeeding.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minimum total sample sizes were determined using PASS 2020 Power Analysis and Sample Size Software (2020). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass based on a repeated-measures analysis of variance with 0 between factor and 1 within factor has 1 group with 15 subjects each for a total of 15 subjects. Each subject is measured 2 times. This design achieves 80% power to test factor W1 if a Geisser-Greenhouse Corrected F Test is used with a 5% significance level and the actual effect standard deviation is 0.330 (an effect size of 0.7).
Data will be analysed using Excel and SPSS statistical packages. Overall changes in visual function variables will be analysed using ANOVA and post-hoc t-tests. Relationships between variables will be investigated using regression techniques. A critical p-value of 0.05 will be used to denote statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
10/02/2023
Actual
Date of last data collection
Anticipated
10/02/2023
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23327 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 38699 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 312381 0
University
Name [1] 312381 0
Unversity of New South Wales -UNSW
Country [1] 312381 0
Australia
Primary sponsor type
University
Name
Unversity of New South Wales -UNSW
Address
UNSW Sydney
High St
Kensington NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 313953 0
None
Name [1] 313953 0
None
Address [1] 313953 0
NA
Country [1] 313953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311739 0
The HREA Panel G: Health, Medical, Community & Social
Ethics committee address [1] 311739 0
Ethics committee country [1] 311739 0
Australia
Date submitted for ethics approval [1] 311739 0
17/05/2022
Approval date [1] 311739 0
20/05/2022
Ethics approval number [1] 311739 0
HC200099

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

Contacts
Principal investigator
Name 122198 0
A/Prof Sieu Khuu
Address 122198 0
University of New South Wales (UNSW)
Faculty of Medicine and Health
School of Optometry and Vision Science
Level 3, Room 3.028
Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 122198 0
Australia
Phone 122198 0
+61 2 9385 4620
Fax 122198 0
Email 122198 0
[email protected]
Contact person for public queries
Name 122199 0
Sieu Khuu
Address 122199 0
University of New South Wales (UNSW)
Faculty of Medicine and Health
School of Optometry and Vision Science
Level 3, Room 3.028
Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 122199 0
Australia
Phone 122199 0
+61 2 9385 4620
Fax 122199 0
Email 122199 0
[email protected]
Contact person for scientific queries
Name 122200 0
Sieu Khuu
Address 122200 0
University of New South Wales (UNSW)
Faculty of Medicine and Health
School of Optometry and Vision Science
Level 3, Room 3.028
Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 122200 0
Australia
Phone 122200 0
+61 2 9385 4620
Fax 122200 0
Email 122200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17310Informed consent form    384785-(Uploaded-12-10-2022-17-42-32)-Study-related document.pdf
17311Ethical approval    384785-(Uploaded-12-10-2022-17-43-10)-Study-related document.Pdf



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.