Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000218493p
Ethics application status
Not yet submitted
Date submitted
5/02/2025
Date registered
27/03/2025
Date last updated
27/03/2025
Date data sharing statement initially provided
27/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Front Surface Aberration Control in Scleral Lenses for Improvement of Visual Quality in Patients with Corneal Ectasia
Scientific title
Front Surface Aberration Control in Scleral Lenses for Improvement of Visual Quality in Patients with Corneal Ectasia
Secondary ID [1] 313887 0
EYESPACE HOA V1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Corneal Ectasia 336558 0
Keratoconus 336559 0
Condition category
Condition code
Eye 333073 333073 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will examine the effects of custom front-surface wavefront correction on visual performance and on the neutralisation of higher-order aberrations in patients with corneal ectasia wearing scleral lenses compared to conventional scleral lenses.
The clinical trial will be single centre and involve five visits over approximately four months.
The investigational devices are the EyeSpace® aberration cancelling (OV) lens and longitudinal spherical aberration (LSA) lens. The OV lens has a custom individualised front surface based on the entire wavefront aberrometry reading in a conventional lens. The LSA lens has -1.00 D of longitudinal spherical aberration on the front surface. The material of the scleral lens will be an FDA-approved polymer for use in rigid contact lenses (Acuity 200™ or fluoroxyfocon A). The device is intended to be worn during the day and removed during hours of sleep. Scleral contact lenses will be fitted by a registered optometrist with training in fitting scleral contact lenses.
Participants are required to wear the lenses for at least two hours a day for 20 days between Visit 3, 4 or 5; and for more than 2 hours on the of day Visit 3, 4 or 5. At the start of each visit the patient will be asked if they have worn the lenses for the required time, if not the visit will be rescheduled. This visit will be rescheduled at least week later to ensure they meet minimum wear time.
The participants will wear all 3 lenses for 4 weeks each with the lenses being swapped at Visit 3, 4 and 5. As the fit of the lenses are the exact same there will be no washout.
Visits will take 1.5 hours a part from visit 5 which requires a three hour break in the middle of the visit. The visits will comprise of an assessment of vision including distance vision, near vision and low contrast vision, an assessment of fit with slit lamp and anterior oct, an ocular health assessment with slit lamp as well as an assessment of residual aberrometry. These assessments will be conducted by an experienced contact lens fitting optometrist.
Intervention code [1] 330472 0
Treatment: Devices
Comparator / control treatment
The control device is an EyeSpace® Conventional Scleral in Acuity 200™. The material and overall design is the same as the investigational device, but without front surface alterations beyond sphere and cylinder correction. Similar to the investigational devices, the control device is intended to be worn during the day and removed during hours of sleep. Scleral contact lenses will be fitted by a registered optometrist with training in fitting scleral contact lenses.
Control group
Active

Outcomes
Primary outcome [1] 340609 0
Changes in monocular high contrast visual acuity between uncorrected, best spectacle correction, Lens A, Lens B and Lens C
Timepoint [1] 340609 0
Baseline and Visit 5 following all treatment
Primary outcome [2] 340610 0
Changes in monocular low contrast visual acuity between uncorrected, best spectacle correction, Lens A, Lens B and Lens C
Timepoint [2] 340610 0
Baseline and Visit 5 following treatment
Primary outcome [3] 340611 0
Numerical difference between uncorrected, Lens A, Lens B and Lens C in root mean square (RMS) of lower-order aberrations (LOA), higher-order aberrations (HOA), trefoil, coma, and spherical aberration with a 5.00 mm pupil
Timepoint [3] 340611 0
Baseline and Visit 5 following treatment
Secondary outcome [1] 444582 0
Proportion of eyes at Visits 3, 4 and 5 that have achieved monocular high contrast visual acuity of 0.00 logMAR or better
Timepoint [1] 444582 0
Baseline and Visit 3, 4 and 5
Secondary outcome [2] 444583 0
Proportion of eyes at Visits 3, 4 and 5 that have achieved monocular low contrast visual acuity of 0.30 logMAR or better
Timepoint [2] 444583 0
Baseline and Visit 3, 4 and 5
Secondary outcome [3] 444584 0
Adverse events over the course of the study
Timepoint [3] 444584 0
All visits

Eligibility
Key inclusion criteria
Are 18 years old or above and 65 years old or below with full legal and mental capacity to volunteer

Have voluntarily agreed to participate in the study by reading and signing the statement of informed consent

Have corneal ectasia based on having a Belin/Ambrosio enhanced ectasia display score of 2.6 or more in either eye on Pentacam imaging

Have no other active ocular disease

Best corrected high contrast LogMAR better than or equal to 0.30 with a conventional scleral lens

Able to achieve pupil diameter greater than 5mm in scotopic conditions
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are under the age of 18 or over the age of 65 or do not have full legal or mental capacity to volunteer

Are unwilling to comply with follow ups

Have a Belin/Ambrosio enhanced ectasia display score of less than 2.6 in both eyes based on Pentacam imaging

Have knowingly used miotic eye drops in the last 3 months

Have visually significant ocular pathology other than irregular astigmatism, including but not limited to corneal or lenticular opacity, and optic nerve or macular disease

Have significant ocular inflammation including conjunctivitis, keratitis and uveitis. If present, the participant can be treated and invited to return for a second screening once resolved.

Are unable to insert, remove or appropriately handle/clean a scleral lens as deemed by the investigator

Have an allergy to any ingredient in the study lens or lens care solutions

Best corrected high contrast logMAR worse than 0.30 with a conventional scleral lens

Have a history of corneal graft, pterygium or ICRS in the study eye

Are unable to achieve pupil diameter greater than 5mm in scotopic conditions

Are participating in any other type of clinical research or study

If the participant's scleral lens fit changes significantly over the course of the trial

Participants that require more than 3 appointments for any given visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2025
Actual
Date of last participant enrolment
Anticipated
11/08/2025
Actual
Date of last data collection
Anticipated
2/02/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318356 0
Commercial sector/Industry
Name [1] 318356 0
EyeSpace
Country [1] 318356 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
EyeSpace
Address
Country
Australia
Secondary sponsor category [1] 320758 0
None
Name [1] 320758 0
Address [1] 320758 0
Country [1] 320758 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316987 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 316987 0
Ethics committee country [1] 316987 0
Australia
Date submitted for ethics approval [1] 316987 0
07/05/2025
Approval date [1] 316987 0
Ethics approval number [1] 316987 0

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

Contacts
Principal investigator
Name 139666 0
Mr Lachlan Hoy
Address 139666 0
Innovative Eye Care 300 Wakefield Street Adelaide SA 5000
Country 139666 0
Australia
Phone 139666 0
+61 088122 6801
Fax 139666 0
Email 139666 0
[email protected]
Contact person for public queries
Name 139667 0
Daniel Moriarty
Address 139667 0
EyeSpace 300 Wakefield Street Adelaide SA 5000
Country 139667 0
Australia
Phone 139667 0
+61 088122 6801
Fax 139667 0
Email 139667 0
[email protected]
Contact person for scientific queries
Name 139668 0
Daniel Moriarty
Address 139668 0
EyeSpace 300 Wakefield Street Adelaide SA 5000
Country 139668 0
Australia
Phone 139668 0
+61 088122 6801
Fax 139668 0
Email 139668 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.