Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000673741
Ethics application status
Approved
Date submitted
4/03/2021
Date registered
9/05/2022
Date last updated
9/05/2022
Date data sharing statement initially provided
9/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel screening method for Keratoconus (conic front surface of the eye) for use in disadvantaged populations
Scientific title
Smartphone Photography Aided Recognition of Keratoconus (SPARK) using contact lenses, fluorescein & anaesthetic to screen populations for keratoconus that do not have access to corneal topography
Secondary ID [1] 303541 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
"SPARK" Trial acronym, which stands for:
Smart-Phone Photography Aided Recognition of Keratoconus
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Keratoconus 320888 0
Condition category
Condition code
Eye 318703 318703 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
The researchers intend to photograph participant's more severely graded eye according to the KISA index, (or the right eye for controls) using a smart phone after applying trial rigid contact lenses. In order to minimise discomfort associated with the application of the contact lens, one drop of Alcaine 0.5% (Proxymetacaine hydrochloride) will be instilled prior to the application of the trial lens. Further, participant's tears are stained using a wetted sodium fluorescein (1 mg) strip to aid the visibility of tears under the contact lens during smart phone photography. The exposure duration to contact lens, topical anaesthesia and fluorescein dye lasts approximately 10 minutes. During which time an anterior eye photograph will be obtained using a smart phone. This photograph taken with the optometrists' smartphone will be input to image processing, and these preceding steps will be collectively known as SPARK. It follows from these steps that SPARK is a technique any optometrist may employ using their personal smartphone, rather than a device sold to the optometrist. A therapeutically endorsed, qualified optometrist will conduct the study at the UNSW School of Optometry and Vision Science by applying the SPARK technique.
Intervention code [1] 323049 0
Early Detection / Screening
Comparator / control treatment
One eye from each participant will be included in the study. This will be the eye with the higher KISA index in the test group, and the right eye in the control group.
The comparator/control group will have participants with normal corneas (no disorder such as keratoconus). This comparator/control group will also be subjected to same exposure (application of trial rigid contact lenses, fluorescein and anaesthetic) as cases (those who are diagnosed as having keratoconus).
No treatment is applied in the study to either group, save the insertion of contact lenses (intervention) to screen for disease by using the SPARK technique outlined. Therefore a description of an active control is applied to the comparator/control group.
Control group
Active

Outcomes
Primary outcome [1] 326636 0
detect a keratoconus index (or indices) that differentiates keratoconus from normal corneas using the corneal shape reconstructed from the post-lens tear film photographs obtained from a smart phone.
Timepoint [1] 326636 0
10 minutes after contact lens insertion
Secondary outcome [1] 392227 0
Using the corneal shape reconstructed from the post-lens tear film photographs we will categorise severity of keratoconus based on one or more keratconus indices:
A list of indices we may apply:
logKISA [1]
Central K [1]
I-S Index [1]
SAI [2]
SRI [2]
E value [3]
Q value [3]
max KISA index [4]
KSI [5]
KCI [5]
RMS Corneal Higher Abberation [6]
Coma Like Abberation [6]

References:
1. Li, X., H. Yang, and Y.S. Rabinowitz, Keratoconus: classification scheme based on videokeratography and clinical signs. Journal of Cataract & Refractive Surgery, 2009. 35(9): p. 1597-1603.
2. Aksoy, S., et al., Topography and higher order corneal aberrations of the fellow eye in unilateral keratoconus. Turkish journal of ophthalmology, 2017. 47(5): p. 249.
3. Tummanapalli, S.S., et al., Evaluation of corneal elevation and thickness indices in pellucid marginal degeneration and keratoconus. Journal of Cataract & Refractive Surgery, 2013. 39(1): p. 56-65.
4. Rabinowitz, Y.S. and K. Rasheed, KISA% index: a quantitative videokeratography algorithm embodying minimal topographic criteria for diagnosing keratoconus. Journal of Cataract & Refractive Surgery, 1999. 25(10): p. 1327-1335.
5. Goebels, S., et al., Staging of keratoconus indices regarding tomography, topography, and biomechanical measurements. American journal of ophthalmology, 2015. 159(4): p. 733-738. e3. (Supplemental Table Data Available at https://www.sciencedirect.com/science/article/pii/S0002939415000434#dtbl1)
6. Alió, J.L. and M.H. Shabayek, Corneal higher order aberrations: a method to grade keratoconus. Journal of Refractive Surgery, 2006. 22(6): p. 539-545.
Timepoint [1] 392227 0
10 minutes after contact lens insertion

Eligibility
Key inclusion criteria
Individuals who are clinically diagnosed as keratoconus in one or both eyes based on standard optometric tests (Test group)
Individuals with no clinical signs of keratoconus or other corneal ectatic conditions (control/comparator group)
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe dry eye
Sensitivity towards rigid contact lenses
Allergies anaesthetic eye drops
Corneal ectasia other than keratoconus,
Current rigid lens wearers (including orthokeratology)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The mean shape index between test group and control group will be assessed using standard independent two-tailed student t-test
Receiver Operating Characteristic (ROC) curves will be plotted for all the keratoconus indices derived and compared between them in terms of Area Under the Curve (AUC). Cut-off values to distinguish between keratoconus and controls will be determined.
A p value <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/05/2022
Actual
Date of last participant enrolment
Anticipated
25/07/2022
Actual
Date of last data collection
Anticipated
25/07/2022
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307965 0
University
Name [1] 307965 0
University of New South Wales
Country [1] 307965 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Optometry and Vision Science Rupert Myer Building (North Wing) University of New South Wales, Gate Barker Street, Kensington, NSW 2033
Country
Australia
Secondary sponsor category [1] 308681 0
None
Name [1] 308681 0
Address [1] 308681 0
Country [1] 308681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307959 0
The UNSW Australia Human Research Ethics Advisory Panels (Low Risk) Comittee HREA Panel G: Health, Medical Community and Social
Ethics committee address [1] 307959 0
UNSW Research Ethics & Compliance Support
Human Research Ethics Advisory Panel
UNSW Sydney NSW 2052 Australia
Ethics committee country [1] 307959 0
Australia
Date submitted for ethics approval [1] 307959 0
01/05/2021
Approval date [1] 307959 0
15/10/2021
Ethics approval number [1] 307959 0
HC210359

Summary
Brief summary
It has been estimated that 1 in every 750 individuals worldwide likely to have keratoconus, a condition that affects the front transparent structure of the eye called cornea. Whereas
normal healthy corneas are generally spherical in shape, eyes with keratoconus assume conic shape thereby affecting vision of the individual. The onset of this condition is generally during adolescence and the progresses until the age of 40. Early detection of this condition is important to apply appropriate clinical management strategies. Currently keratoconus is detected early by the use of a diagnostic instrument called corneal topographer that assesses shape of the front surface of the eye and provide certain corneal indices to differentiate keratoconus from normal eyes. Unfortunately, corneal topographers are expensive and are rarely available in rural optometric practices making it difficult to detect keratoconus in the rural areas.

The primary purpose of this research study is develop a smart phone based photography technique that indirectly captures the shape of the cornea, the shape indices thus determined from the reconstructed corneal shape will help differentiate keratoconus from normals, eliminating the dependency on the expensive corneal topographers that are rarely available in rural optometric practices.

Individuals aged between 18 and 40 years who are diagnosed to have keratoconus from various optometry and ophthalmology practices in Sydney are enrolled in this study. Individuals with healthy corneas falling in the same age range will also be enrolled into this study but will be classified as controls. Participants who are currently rigid contact lens wearers, have intolerance to rigid contact lens wear and have astigmatism more than 2 dioptre are not eligible to participate in this study.

Standard optometric tests including vision test, determination of spectacle power, assessment of corneal shape (topography) and a anterior eye health assessment using a slit lamp will be performed.

Rigid contact trial lenses will be applied to one or both eyes. A standard orange dye (Sodium fluorescein) will then be applied to aid the visibility of tears under the contact lens. Anaesthetic eye drops will be used to avoid any discomfort that may arise from the applied rigid contact lenses. Anterior eye photograph, while the contact lens is in place, will be captured using a smart phone. A custom software program will analyse the dyed tear layer behind the contact lens to reconstruct underlying corneal shape providing corneal shape indices. These corneal shape indices will be used to detect keratoconus from normal eyes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109046 0
Dr Dr Maitreyee Roy
Address 109046 0
Rupert Myers Building, Barker St, Kensington NSW 2033, Australia
School of Optometry and Vision Science, Address.
School of Optometry and Vision Science
Level 3, Room 3.025
North Wing, Rupert Myers Building
Country 109046 0
Australia
Phone 109046 0
+61 2 9385 7874
Fax 109046 0
+61 2 9313 6243
Email 109046 0
[email protected]
Contact person for public queries
Name 109047 0
Mr Jack Gordon
Address 109047 0
Rupert Myers Building, Barker St, Kensington NSW 2033, Australia
School of Optometry and Vision Science, Address.
School of Optometry and Vision Science
Level 3, Room 3.025
North Wing, Rupert Myers Building

Country 109047 0
Australia
Phone 109047 0
+61 2 9385 7874
Fax 109047 0
+61 2 9313 6243
Email 109047 0
[email protected]
Contact person for scientific queries
Name 109048 0
Mr Vinod Maseedupally
Address 109048 0
Rupert Myers Building, Barker St, Kensington NSW 2033, Australia
School of Optometry and Vision Science, Address.
School of Optometry and Vision Science
Room 3.055
North Wing, Rupert Myers Building
Country 109048 0
Australia
Phone 109048 0
+61 2 9385 9233
Fax 109048 0
+61 2 9313 6243
Email 109048 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
Data Collection may contain medical information and relate to a highly sensitive classification


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.