ANZCTR - Registration

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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

4/08/2024

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]

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

Condition category

Condition code

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

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]

10 minutes after contact lens insertion

Secondary outcome [1]

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]

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

14/09/2024

Actual

Date of last participant enrolment

Anticipated

14/06/2025

Actual

Date of last data collection

Anticipated

14/06/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New South Wales

Address [1]

School of Optometry and Vision Science Rupert Myer Building (North Wing) University of New South Wales, Gate Barker Street, Kensington, NSW 2033

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The UNSW Australia Human Research Ethics Advisory Panels (Low Risk) Comittee HREA Panel G: Health, Medical Community and Social

Ethics committee address [1]

UNSW Research Ethics & Compliance Support 
Human Research Ethics Advisory Panel 
UNSW Sydney NSW 2052 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2021

Approval date [1]

15/10/2021

Ethics approval number [1]

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

Dr Dr Maitreyee Roy

Address

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

Australia

Phone

+61 2 9385 7874

Fax

+61 2 9313 6243

maitreyee.roy@unsw.edu.au

Contact person for public queries

Name

Jack Gordon

Address

Country

Australia

Phone

+61 2 9385 7874

Fax

+61 2 9313 6243

z3376584@ad.unsw.edu.au

Contact person for scientific queries

Name

Vinod Maseedupally

Address

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

Australia

Phone

+61 2 9385 9233

Fax

+61 2 9313 6243

vinodm@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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