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Trial registered on ANZCTR


Registration number
ACTRN12622000807752
Ethics application status
Approved
Date submitted
31/05/2022
Date registered
8/06/2022
Date last updated
8/06/2022
Date data sharing statement initially provided
8/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comfort and eye health in scleral shell wearers.
Scientific title
The effect of ocular physiology and prosthesis material on comfort and ocular health in scleral shell prosthesis wearers.
Secondary ID [1] 307245 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular disfigurement 326491 0
Dry eye disease 326492 0
Scleral shell prosthesis wear 326493 0
Condition category
Condition code
Eye 323756 323756 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the effect of scleral shell prosthesis hydrophilicity (prosthesis material wettability) on prosthesis comfort of wear, required cleaning, lubrication use, dry eye symptoms, tear film features, prosthesis deposition, ocular microbiology, and ocular discharge in people who currently wear a scleral shell prosthesis. A minimum of 25 participants will be recruited.

The study will require 3 visits:
At visit 1, a full ocular and medical history will be taken and baseline assessments of ocular health will be made. Participants will have their scleral shell prosthesis of standard poly(methylmethacrylate) material professionally cleaned and polished and commence wearing their prosthesis for 4-6 weeks. During the 4-6 week wearing period, participants will record their frequency of prosthesis cleaning, lubrication, and wearing times on a form.
Visit 1 will take no more than 1 hour.

At visit 2, assessments of prosthesis comfort of wear, required cleaning, lubrication use, dry eye symptoms, tear film features, prosthesis deposition, ocular microbiology, and ocular discharge will be made. Their prosthesis will then be re-surfaced with a poly(methylmethacrylate) of increased hydrophilicity (increased wettability) and a further 4-6 weeks of prosthesis wear will be commenced. During the 4-6 week wearing period, participants will record their frequency of prosthesis cleaning, lubrication, and wearing times on a form.
Visit 2 will take no more than 1 hour.

At visit 3, assessments of prosthesis comfort of wear, required cleaning, lubrication use, dry eye symptoms, tear film features, prosthesis deposition, ocular microbiology, and ocular discharge will be repeated.
Visit 3 will take no more than 1 hour.

During the study participants wear their scleral shell prosthesis as they normally would, with no requirement to change the activities or behaviours. There will be no washout period.

The standard poly(methylmethacrylate) material is the control and the poly(methylmethacrylate) of increased hydrophilicity is the intervention. The hydrophilicity of poly(methylmethacrylate) can be altered by adjusting the ratios of the usual constituents of poly(methylmethacrylate) during processing. No additional constituents or ingredients are used or added when the hydrophilicity is adjusted, and the standard lab processing procedures are carried out unchanged. A paper has been published on this: Pine, K. R., De Silva, K., Zhang, F., Yeoman, J., & Jacobs, R. (2021). Towards improving the biocompatibility of prosthetic eyes. Heliyon, 7(2), e06234. doi:https://doi.org/10.1016/j.heliyon.2021.e06234. All participants will obtain the standard poly(methylmethacrylate) material first, and the hydrophilic poly(methylmethacrylate) material, as unavoidable processing issues will occur if the shell is resurfaced more than once. Participants will not be informed which of the two veneer materials they obtain at their visits, or of possible differences in the materials.
The ocular health assessments made during the study are commonly used ophthalmological and optometric practice, and will be carried out by an experienced research team of optometrists, ophthalmologists and ocularists (all clinicians have over 15 years experience in their respective fields). The study will be carried out at private and university eye clinics.
Intervention code [1] 323682 0
Treatment: Devices
Comparator / control treatment
The study intervention (prosthesis material of increased hydrophilicity) is being compared to the standard prosthesis material. Participants will be given both prosthesis materials during the study (crossover study design).

Observations of ocular health (eg dry eye measures) will also be compared between the unaffected eye and affected eye at the baseline visit (visit 1).
Control group
Active

Outcomes
Primary outcome [1] 331520 0
Non-invasive tear breakup time using the Oculus Keratograph 5M instrument (both unaffected and affected eyes).
Timepoint [1] 331520 0
Baseline, 4-6 weeks after wearing a prosthesis of standard material, and again 4-6 weeks after wearing a prosthesis of increased hydrophilicity.
Primary outcome [2] 331521 0
Prosthesis deposits evaluated against established grading scales using standardised methods. Reference: Pine KR, Sloan B, Jacobs RJ. The development of measurement tools for prosthetic eye research. Clinical & experimental optometry 2013;96:32-38.
Timepoint [2] 331521 0
Baseline, 4-6 weeks after wearing a prosthesis of standard material, and again 4-6 weeks after wearing a prosthesis of increased hydrophilicity.
Primary outcome [3] 331522 0
Prosthesis comfort (on visual analogue scale)
Timepoint [3] 331522 0
Baseline, then 4-6 weeks after wearing a prosthesis of standard material, and again 4-6 weeks after wearing a prosthesis of increased hydrophilicity.
Secondary outcome [1] 410164 0
Microbiology culture from swab of the tears and conjunctiva (both unaffected and affected eyes).
Timepoint [1] 410164 0
Baseline, 4-6 weeks after wearing a prosthesis of standard material, and repeated 4-6 weeks after wearing a prosthesis of increased hydrophilicity.
Secondary outcome [2] 410416 0
Tear meniscus height using the Oculus Keratograph 5M instrument (both unaffected and affected eyes).
Timepoint [2] 410416 0
Baseline, then 4-6 weeks after wearing a prosthesis of standard material, and again 4-6 weeks after wearing a prosthesis of increased hydrophilicity.
Secondary outcome [3] 410417 0
Bulbar redness using the Oculus Keratograph 5M instrument (both unaffected and affected eyes).
Timepoint [3] 410417 0
Baseline, then 4-6 weeks after wearing a prosthesis of standard material, and again 4-6 weeks after wearing a prosthesis of increased hydrophilicity.
Secondary outcome [4] 410418 0
Dry eye symptoms on validated Ocular Surface Disease Index (OSDI) questionnaire.
Timepoint [4] 410418 0
Baseline, then 4-6 weeks after wearing a prosthesis of standard material, and again 4-6 weeks after wearing a prosthesis of increased hydrophilicity.
Secondary outcome [5] 410419 0
Dry eye symptoms on validated Dry Eye Questionnaire 5 (DEQ-5) questionnaire.
Timepoint [5] 410419 0
Baseline, then 4-6 weeks after wearing a prosthesis of standard material, and again 4-6 weeks after wearing a prosthesis of increased hydrophilicity.

Eligibility
Key inclusion criteria
People with one or two non-functional, disfigured eyes who currently wear a scleral shell prosthesis. The definition used for a non-functional eye is that of legal blindness and the eye must have no visual potential even with refractive (glasses), medical or surgical intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Although the clinical assessments planned for this study are routinely carried out in clinical practice and research, data for the dry eye measures have not been reported in scleral shell wearers in the literature. Accordingly, data available from the TFOS DEWS II Group (Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II Diagnostic Methodology report. The Ocular Surface 2017;15:539-574) and in consultation with a biostatistician (power calculations using Genstat), indicate that to achieve a significance of 5% with a power of 90%, the minimum number of participants required for each study arm are:
4 for tear meniscus height (using Keratograph 5M),
23 for bulbar redness;
5 for non-invasive tear breakup time (using Keratograph 5M)
(when the experiment is designed to compare samples of different groups):
The limited number of scleral shell wearers in New Zealand (estimated to be 550 across all of NZ) will make recruiting participants more challenging, but given that our measures will be within individuals (i.e. comparing measures between their affected and unaffected eye; or in their affected eye at different points in time) we would expect the population standard deviation to be reduced, and so would require smaller samples than shown above for the given power (and significance of 5%). However, given the limited data, it is not possible to calculate the lower limit of the sample size. On balance, a minimum of 25 participants for this study.

Descriptive variables will be reported for all variables (demographics including age, gender, ethnicity, location, categories of ocular history and morphology, dry eye questionnaire scores, baseline clinical measures). Baseline clinical measures will be compared between the affected eye and the unaffected eye, and over the course of the study.

Demographic factors, category of ocular history and morphology and baseline clinical measures will be correlated with reported comfort, and length of comfortable continuous wear periods. Correlations between the category of ocular history and morphology, shell deposition, cleaning frequency, clinical measures and microbiology findings for the materials will also be assessed.
The Shapiro-Wilks tests will be employed to test data normality. Means will be calculated with t-tests and ANOVAs and post-hoc testing, while proportions and categorical variables will be assessed with Chi-squared testing. Variables reaching significance, via ANOVA testing or correlation assessment as appropriate, may be included in a multiple regression analysis to test for independent predictive values of the different parameters. Statistical analysis will be carried out in consultation with a biostatistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 24809 0
New Zealand
State/province [1] 24809 0
Auckland

Funding & Sponsors
Funding source category [1] 311541 0
University
Name [1] 311541 0
University of Auckland
Country [1] 311541 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland,
Private Bag 92019,
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 312956 0
None
Name [1] 312956 0
Address [1] 312956 0
Country [1] 312956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310996 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310996 0
Health and Disability Ethics Committee
Ministry of Health
PO Box 5013
Wellington, 6011
Ethics committee country [1] 310996 0
New Zealand
Date submitted for ethics approval [1] 310996 0
10/03/2022
Approval date [1] 310996 0
24/05/2022
Ethics approval number [1] 310996 0
2022 FULL 11865

Summary
Brief summary
Scleral shell prosthesis practice is an under-researched topic, and subsequently believed to be an under-utilised way to provide
rehabilitation to those with a non-functional, disfigured eye. Beyond the restoration of the eye’s appearance, eyelid position, and
blink, scleral shell prostheses importantly impact positively on the psychosocial functioning, wellbeing, and quality of life of the wearer.

As scleral shell prosthesis use gains favour and there are efforts to make scleral shells more accessible, there is a growing need for evidence-based information on their effects on the eye surface and the tear film. Also, scleral shell prosthesis wear is not always comfortable and it is unclear why. This study aims to look at the effect of scleral shell prosthesis wear on eye health, and the factors that affect comfort of wear. This study will also look at how altering the wettability of the prosthesis surface may affect eye health, dry eye, eye discharge and wearer comfort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119630 0
Dr Stuti Misra
Address 119630 0
Department of Ophthalmology, The University of Auckland.
85 Park Road
Grafton 1023
Auckland
Country 119630 0
New Zealand
Phone 119630 0
+64 9 923 6582
Fax 119630 0
Email 119630 0
[email protected]
Contact person for public queries
Name 119631 0
Janice Yeoman
Address 119631 0
Department of Ophthalmology, The University of Auckland.
85 Park Road
Grafton 1023
Auckland
+64 9 373 7999 extension 85892
Country 119631 0
New Zealand
Phone 119631 0
+64 9 373 7999
Fax 119631 0
Email 119631 0
[email protected]
Contact person for scientific queries
Name 119632 0
Stuti Misra
Address 119632 0
Department of Ophthalmology, The University of Auckland.
85 Park Road
Grafton 1023
Auckland
Country 119632 0
New Zealand
Phone 119632 0
+64 9 923 6582
Fax 119632 0
Email 119632 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
We have not planned to share individual participant data at this time given the number participants will be small and their unique clinical circumstances might not allow complete de-identification. However, data will be shared with the patients and if requested, their GPs and other health care providers.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16258Informed consent form  [email protected]
16259Ethical approval  [email protected]



Results publications and other study-related documents

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