Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000175370
Ethics application status
Approved
Date submitted
27/01/2017
Date registered
2/02/2017
Date last updated
31/08/2023
Date data sharing statement initially provided
20/09/2019
Date results provided
20/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of binocular vision disorders on contact lens dissatisfaction in non-presbyopic adult contact lens wearers.
Scientific title
A prospective study in a population of myopic non-presbyopic adult contact lens wearers to determine a suitable measure of contact lens dissatisfaction and to determine the extent to which binocular vision disorders contribute to contact lens dissatisfaction.
Secondary ID [1] 291017 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens dissatisfaction 301793 0
Binocular vision disorders 301794 0
Condition category
Condition code
Eye 301484 301484 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be a prospective study in a population of myopic non-presbyopic adult contact lens wearers. On successful enrollment, participants will complete two validated questionnaire comprising the Convergence Insufficiency Syndrome Survey (CISS) and the Contact Lens Dry Eye- Questionnaire-8 (CLDEQ-8). The CISS assesses symptoms arising from binocular vision disorders and the CLDEQ-8 assessed symptoms arising from contact lens dryness. Each participant will complete questionnaires according to a pre-determined randomization plan to minimize potential bias arising from completing questionnaires in the same order. Participants will be given the second questionnaire only after completing and returning the first questionnaire.
A standard, optometric binocular vision assessment will be performed and participants will be classified as either having a binocular vision disorder or not having a binocular vision disorder.
Participants will be sent a set of three contact lens dissatisfaction questionnaires after completing the standard, optometric binocular vision assessment. These questionnaires comprise the Contact Lens Impact on Quality-of-life (CLIQ), the Ocular Surface Disease Index (OSDI) and the Ranked Symptom Survey (RSS). The CLIQ is a validated quality-of-life questionnaire aimed specifically at non-presbyopic contact lens wearers. The OSDI is a validated questionnaire comprising three subscales assessing assess vision-related function, ocular symptoms and environmental triggers. The RSS comprises three subscales assessing discomfort, vision dissatisfaction and lens handling dissatisfaction. On completion and return of the questionnaires, a second set of the same questionnaires will be sent within 5-7 days. Participants will complete and return the second set of questionnaires. Each participant will complete each set of three questionnaires according to a pre-determined randomization plan to minimize potential bias arising from completing questionnaires in the same order.
Intervention code [1] 297010 0
Not applicable
Comparator / control treatment
The control group will be participants diagnosed as not having a binocular vision disorder
Control group
Active

Outcomes
Primary outcome [1] 300878 0
The utility of the Contact Lens Impact on Quality-of-life (CLIQ), the Ocular Surface Disease Index (OSDI) and the Ranked Symptom Survey (RSS) questionnaires to measure contact lens dissatisfaction in myopic, non-presbyopic adults, as assessed by correlations between the Convergence Insufficiency Syndrome Survey and each of the three questionnaires (CLIQ, OSDI, RSS).
Timepoint [1] 300878 0
On the day of enrolment (completion of the CISS), 2-3 days following enrolment (completion of first set of CLIQ, OSDI, RSS) and 7-9 days (completion of second set of CLIQ, OSDI, RSS).
Primary outcome [2] 300912 0
The utility of the CLIQ, OSDI and RSS questionnaires to measure contact lens dissatisfaction in myopic, non-presbyopic adults, as assessed by correlations between the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and each of the three questionnaires (CLIQ, OSDI, RSS).
Timepoint [2] 300912 0
On the day of enrolment (completion of the CLDEQ-8), 2-3 days following enrolment (completion of first set of CLIQ, OSDI, RSS) and 7-9 days (completion of second set of CLIQ, OSDI, RSS).
Primary outcome [3] 300913 0
The utility of the CLIQ, OSDI and RSS questionnaires to measure contact lens dissatisfaction in myopic, non-presbyopic adults, as assessed by repeatability of each of the three questionnaires (CLIQ, OSDI, RSS).
Timepoint [3] 300913 0
2-3 days following enrolment (completion of first set of CLIQ, OSDI, RSS) and 7-9 days (completion of second set of CLIQ, OSDI, RSS
Secondary outcome [1] 331092 0
Presence of a binocular vision disorder as determined by standard optometric testing comprising monocular and binocular high contrast visual acuity and 6 m and 40 cm, dissociated heterophorias at 3 m and 40 cm, fixation disparity at 40 cm, accommodative facility at 40 cm, near point of accommodation, near point of convergence, stereopsis at 40 cm, vergence ranges at 6 m and 40 cm, positive and negative relative accommodation at 40 cm, near autorefraction and contact lens dissatisfaction as determined from the primary outcome (either the CLIQ, OSDI, RSS)
Timepoint [1] 331092 0
On the day of enrolment (completion of the standard optometric testing), 2-3 days following enrolment (completion of first set of CLIQ, OSDI, RSS) and 7-9 days (completion of second set of CLIQ, OSDI, RSS).

Eligibility
Key inclusion criteria
Participants must:
*Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
*Be between 18-40 years old, male or female.
*Have less than or equal to 1.00 D cylindrical power in either eye.
*Achieve at least 0.20 LogMAR (6/9.5) or better in each eye with no more than a one-line difference (0.10 LogMAR) between eyes with current contact lenses.
*Willing to comply with the clinical trial as directed by the Investigator.
*Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses.
*Be an experienced spherical contact lens wearer with current contact lens prescription at least one week old.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants must not have:
*Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
*Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
*Use of or a need for concurrent category S3 and above ocular medication at enrolment.
*Eye surgery within 12 weeks immediately prior to enrolment for this trial.
*Previous corneal refractive surgery.
*Previous surgery on the extra ocular muscles.
*Contraindications to contact lens wear.
*Currently enrolled in another clinical trial.
*Pregnancy. Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The two objectives of this trial require different sample sizes, with the objective of determining the extent to which binocular-vision disorders contribute to CL dissatisfaction requiring the larger sample. The sample size will therefore be based on this objective.

Previous data suggests the mean difference +/- SD in the ocular surface disease index scores between participants identified as symptomatic on either the convergence insufficiency symptoms survey or contact lens dry eye questionnaire-8 = 9 +/- 11 and 27% of participants have a binocular vision disorder. Therefore 15 participants with a binocular vision disorder and 56 participants without a binocular vision disorder (71 participants in total) are required to reject the null hypothesis at the 5% level of significance and 80% power.

Participants will be enrolled until the required numbers in each category are achieved, to a maximum of 100 participants.
Participants who have commenced the clinical trial will be included in the analysis dataset.

Questionnaires will be scored as per published instructions. The correlation of dissatisfaction questionnaires with binocular vision questionnaires will be assessed using non-parametric Spearman Correlation. Repeatability of dissatisfaction questionnaires will be assessed using paired non-parametric tests, Bland-Altman plots and by estimating the co-efficient of repeatability.

Data will also be summarised as means +/- standard deviations. No transformation is likely to be required. Scores between questionnaires will be compared using student t-tests.

Participants will be categorised into two trial groups—those with a binocular vision disorder and those without a binocular vision disorder. The level of dissatisfaction will be compared between participant groups using non-parametric group tests such as Wilcoxon or Mann-Whitney tests and parametric tests such as t-test based on the assumptions of normality. The level of dissatisfaction will be determined as item totals for each questionnaire.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2017
Actual
13/04/2017
Date of last participant enrolment
Anticipated
19/02/2018
Actual
24/07/2018
Date of last data collection
Anticipated
26/02/2018
Actual
6/08/2018
Sample size
Target
71
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295445 0
Charities/Societies/Foundations
Name [1] 295445 0
Brien Holden Vision Institute
Country [1] 295445 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5, Rupert Myers Building
Gate 14, Barker Street University of New South Wales,
NSW 2052
Country
Australia
Secondary sponsor category [1] 294265 0
University
Name [1] 294265 0
School of Optometry and Vision Science, University of new South Wales
Address [1] 294265 0
Level 3, Rupert Myers Building
Gate 14, Barker Street University of New South Wales,
NSW 2052
Country [1] 294265 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296776 0
Bellberry Limited
Ethics committee address [1] 296776 0
Ethics committee country [1] 296776 0
Australia
Date submitted for ethics approval [1] 296776 0
27/01/2017
Approval date [1] 296776 0
16/02/2017
Ethics approval number [1] 296776 0
2017-01-069

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

Contacts
Principal investigator
Name 72022 0
Mr Daniel Tilia
Address 72022 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building
Gate 14 Barker St, University of New South Wales
NSW 2052
Country 72022 0
Australia
Phone 72022 0
+61293857516
Fax 72022 0
Email 72022 0
[email protected]
Contact person for public queries
Name 72023 0
Daniel Tilia
Address 72023 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building
Gate 14 Barker St, University of New South Wales
NSW 2052
Country 72023 0
Australia
Phone 72023 0
+61293857516
Fax 72023 0
Email 72023 0
[email protected]
Contact person for scientific queries
Name 72024 0
Daniel Tilia
Address 72024 0
Brien Holden Vision Institute
Level 5, Rupert Myers Building
Gate 14 Barker St, University of New South Wales
NSW 2052
Country 72024 0
Australia
Phone 72024 0
+61293857516
Fax 72024 0
Email 72024 0
[email protected]

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


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
SourceTitleYear of PublicationDOI
EmbaseAssociations between Binocular Vision Disorders and Contact Lens Dissatisfaction.2021https://dx.doi.org/10.1097/OPX.0000000000001780
N.B. These documents automatically identified may not have been verified by the study sponsor.