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Trial registered on ANZCTR


Registration number
ACTRN12622000709741
Ethics application status
Approved
Date submitted
24/03/2022
Date registered
17/05/2022
Date last updated
17/05/2022
Date data sharing statement initially provided
17/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Early-Stage Testing and Assessment of Ophthalmic Lens Prototypes (The PESTA Study)
Scientific title
A prospective, non-randomized, non-dispensing clinical trial to assess the objective and subjective visual performance of ophthalmic lens prototypes (PESTA Study) in adults.
Secondary ID [1] 304656 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractive error that requires optical correction 322608 0
Condition category
Condition code
Eye 320221 320221 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prototypes will be worn monocularly or binocularly, over the eye/s with best subjective vision with the habitual correction or best-corrected subjective refraction performed by an optometrist, for a minimum of 20 minutes. Participants may be asked to wear up to 3 prototypes during each visit. The total duration of the study visit is up to 90 minutes. Each participant may be asked to wear a minimum of 6 and a maximum of 30 prototypes. Participants will need to attend a minimum of two study visits in order to test the minimum of 6 prototype lenses, or at least 10 visits if they choose to test all 30 prototypes.
The commercially available control lenses are:
- Active control 1: Miyosmart manufactured by Hoya, Japan;
- Active control 2: Stellest manufactured by Essilor, France;
- Passive control: Single vision lens.
The prototype lenses all have a similar central optical design to the active controls to correct the refractive error, however, their peripheral optical designs all differ in refractive power to the controls.


Intervention code [1] 321014 0
Treatment: Devices
Comparator / control treatment
Active and passive controls are used in this study and are commercially available. Active controls will be commercially available multifocal designs and passive control lenses will be commercially available spherical designs.
The study duration may be up to 90 minutes.
All participants will be required to wear control lenses for a minimum of 20 minutes. All participants will wear at least one active control lens and may be selected to wear the passive control lens based on their vision profile.
Control group
Active

Outcomes
Primary outcome [1] 328090 0
To compare visual acuity (high and low contrast) thresholds of ophthalmic prototypes. This is a composite outcome. These outcomes will be measured using visual acuity charts.
Timepoint [1] 328090 0
The determination of visual acuity thresholds with ophthalmic prototypes. The visual acuity can be assessed anytime within 20 minutes of wearing each prototype.
Secondary outcome [1] 397590 0
To compare subjective vision gradings assessed using a questionnaire that includes visual reference scales. The questionnaire is designed for this specific study.
Timepoint [1] 397590 0
The subjective vision quality will be assessed anytime within 90 minutes of wearing each prototype.
Secondary outcome [2] 408190 0
To compare the visual satisfaction with the ophthalmic prototypes assessed using a questionnaire. The questionnaire is designed for this specific study.
Timepoint [2] 408190 0
The satisfaction of ophthalmic prototypes will be assessed anytime within 90 minutes of wearing each prototype.

Eligibility
Key inclusion criteria
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be 18years and above.
- Willing to comply with the wearing of the study lenses and the clinical trial visit schedule as directed by the Investigator.
- Have ocular health findings considered to be “normal”
- Spherical prescription range of +6.00D to -6.00DS inclusive and astigmatism <-2.00DC.Reading add power of <+3.00D
- Vision of 6/7.5 (20/25) or better in each eye with or without correction.
- Spectacle and/or contact lens wearers or participants not requiring any optical correction.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Have strabismus and/or amblyopia.
- Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
- Any systemic disease that adversely affects ocular health e.g. diabetes, Graves’ disease, and autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogren’s syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- Previous corneal refractive surgery.
- Known allergy or intolerance to ingredients in any of the clinical trial products.
- Pregnancy*.
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.*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

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
A minimum of 10 participants is required in order to demonstrate a statistically significant paired difference between the control and each iteration in visual acuity of 0.1 ±0.1 log MAR units at the 5% level of significance and 80% power. The minimum sample size is a requirement for each lens design. The sample size is not adjusted for dropouts due to the short nature of each stage.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2022
Actual
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34535 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 309020 0
Other Collaborative groups
Name [1] 309020 0
Brien holden vision institute limited
Country [1] 309020 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brien holden vision institute limited
Address
Level 4, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 309956 0
None
Name [1] 309956 0
Address [1] 309956 0
Country [1] 309956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308903 0
Bellberry Limited
Ethics committee address [1] 308903 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 308903 0
Australia
Date submitted for ethics approval [1] 308903 0
16/06/2021
Approval date [1] 308903 0
15/07/2021
Ethics approval number [1] 308903 0

Summary
Brief summary
A prospective, non-dispensing study to assess the objective and subjective visual performance of ophthalmic prototypes. Up to 150 participants to be enrolled in the study, with a minimum of 10 participants included in the assessment of each prototype. The prototypes will be worn monocularly or binocularly, over the eye/s with best subjective vision with habitual correction or best-corrected subjective refraction, for a minimum of 20 minutes. In monocular measures, the non-measuring eye will be occluded during testing. Measures of visual acuity thresholds, visual function, and subjective vision gradings will be taken while wearing the prototypes. Each individual participant may test multiple prototypes and may test multiple prototypes at each study visit. All participants will undergo evaluation wearing relevant active and/or passive controls at the study visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112286 0
Dr Divya Jagadeesh
Address 112286 0
Brien Holden Vision Institute, Level 5, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 112286 0
Australia
Phone 112286 0
+61 2 90650700
Fax 112286 0
Email 112286 0
[email protected]
Contact person for public queries
Name 112287 0
Luke Seesink
Address 112287 0
Brien Holden Vision Institute, Level 5, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 112287 0
Australia
Phone 112287 0
+61 2 90650721
Fax 112287 0
Email 112287 0
[email protected]
Contact person for scientific queries
Name 112288 0
Divya Jagadeesh
Address 112288 0
Brien Holden Vision Institute, Level 5, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 112288 0
Australia
Phone 112288 0
+61 2 90650700
Fax 112288 0
Email 112288 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?

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.