Is the Use of a Steam Mask an Effective Treatment for Paediatric Chalazion in Comparison to Traditional Warm Compresses?

Overview

Is the use of a steam mask an effective treatment for paediatric chalazion in comparison to traditional warm compresses? This study will aim to assess the difference between these two methods.

Protocol Is the use of a steam mask an effective treatment for paediatric chalazion in comparison to traditional warm compresses? Background Chalazia are chronic sterile lipogranulomas of the meibomian or Zeis glands that can be refractory in nature due to retained sebaceous secretions. Histopathology of chalazia identifies a chronic inflammatory picture, with extracellular fat deposits surrounded by lipid-laden epithelioid cells, multinucleated giant cells and lymphocytes. The condition can often be associated with diagnoses, such as blepharitis, meibomian gland dysfunction and dry eye disease. Chalazia will often present as a gradual, painless and round lesion on the either the upper or lower eyelid. It is expected to be non-tender (unless associated with acute inflammation due to infection), non-fluctuant and non-erythematous, and can either present as a single lesion (chalazion) or as multiple lesions (chalazia). Symptoms can present as reduced vision, epiphora, irritation and cosmetic concerns. For paediatric chalazion, an incidence of 2% has been found, which would account for approximately 288,071 of the UK population aged under the age of 18 years, according to population statistics. The condition is known to be benign and self-limiting in nature, but time until resolution can vary, and therefore treatment is often sought. Management of chalazia usually begins with warm compresses, eyelid massage and eyelid hygiene, unless the patient presentation dictates a more medicalised approach, for example, in cases of cellulitis. Warm compresses provide heat to the chalazion in order to melt the meibum obstructing the meibomian gland. The average melting temperature of meibum is approximately 32oC, increasing to approximately 35oC when there is an obstruction or altered secretions, and therefore it is recommended to achieve a heat of 40oC for therapeutic treatment. A secondary benefit of a heat source in the form of a warm compress is due to activation of the heat shock response and subsequent expression of localised heat shock proteins (HSP). HSPs maintain cellular protein homeostasis (proteostasis) by acting as molecular chaperones and assisting in folding of polypeptides, and other cellular activity, ensuring the normal functioning of cells. Therefore, once activated, the HSPs will assist in functions such as degradation of misfolded proteins and apoptosis regulation, both important functions for cells/tissue damaged by inflammation. HSPs have also been found to inhibit the transcription of genes encoding pro-inflammatory cytokines. Histopathological analysis of chalazion shows the presence of inflammatory cells, and therefore the presence of a heat source may help inhibit the inflammatory response of the chalazion and promote normal functioning of cells. In experimental disease models, HSPs have been shown to prevent or arrest inflammatory damage for patients with chronic inflammatory diseases. As a chalazion is a chronic inflammatory condition, activation of HSPs at the site of the heat source may reduce the inflammatory component of the condition. A warm compress should maintain a temperature of 45oC to achieve therapeutic heat for the treatment of chalazia. This can be done by; optimising the contact between the warm compress and eyelids; replacing the compress every 2 minutes; and using for at least 4 minutes to achieve an inner eyelid temperature of 40oC. Studies suggests that patients often develop their own techniques of performing warm compress, lid massage and lid hygiene, despite instructions; resulting in suboptimal and ineffective treatment that will likely be abandoned. Ineffective techniques could include replacing the compresses too often, starting with compresses that are too hot or too cold or stopping the application too early. These techniques can often result in: the meibum being too viscous, compresses being too warm or massage being too forceful, which can cause discomfort/pain and harm to the ocular surface. Heat masks can be used as an alternative to warm compresses, providing a consistent level of heat to the eyelids, without the need to frequently re-heat or hold the compress in place. Heated eye masks use compressive heat, whereby the mask makes contact with the eyelid surface to achieve therapeutic heat. This can be uncomfortable and can create visual distortion. Compressive heat can induce transient visual degradation with increased subjective blur, which can be concerning for patients, and result in reduced compliance. Due to differences in facial features, it cannot be guaranteed that all areas of the eyelids will receive the desired therapeutic heat, and therefore results can be inconsistent. When using a heat mask, a greater temperature is achieved in the lower eyelids in comparison to the upper eyelids, with the warmest areas being at the centre of the mask. Alternative treatments are available, such as, topical antibiotics and steroids, but no statistical difference in resolution has been found when comparing a hot compress, tobramycin and dexamethasone. Triamcinolone acetonide injection can be used to treat chalazion and has shown to result in resolution of chalazia in a high percentage of patients. However, the use of a triamcinolone acetonide injection has been shown to result in hypopigmentary skin changes. Incision and curettage of chalazia has also been found to be equally successful in resulting in resolution of chalazia. Both of these procedures would require a general anaesthetic for paediatric patients, and can be associated with risks of scarring and post-operative pain, and are also associated with a higher cost to the NHS. Rationale Due to the lack of literature identifying an effective, non-invasive treatment for chalazion, there is a potential to investigate novel treatments that may provide a quicker resolution without requiring an expensive and invasive procedure. The ideal conservative treatment using heat would ensure a consistent, effective and equal temperature is achieved to both upper and lower eyelids, with a comfortable, quick and convenient experience for the user. Such a treatment may come in the form of the MantaTM Steam Mask, a steam mask using eye cups that contain self-hydrating natural zeolite beads that cup each eye and release heated steam when microwaved. The MantaTM Steam Mask can reach a temperature of 50oC when microwaved as per instructions. This heat can be maintained for up to 5-10 minutes. The heated steam is free flowing, ensuring even distribution of heat across all areas of the upper and lower eyelids, and the strap is adjustable to ensure an effective and comfortable fit for those with a head circumference larger than 50cm. The MantaTM Steam Mask appears to account for the short-comings of warm compresses and heat masks, with the added benefit of utilising steam. The moisture from the steam masks can block the sweat glands, preventing the body's natural cooling mechanism, and therefore, temperatures can achieve therapeutic heat levels quicker. Moisture also provides hydration which is essential in the functioning of cutaneous processes, such as, desquamation and maturation of the stratum corneum. The moisture will soften the skin and loosen debris and dead skins cells on the eyelids, resulting in effective eyelid cleansing when wiping, and subsequent unclogging of the meibomian gland openings. Hydration can also be soothing for eyes that are irritated by chalazia, therefore improving compliance with treatment. An additional benefit the of the MantaTM Steam Mask is the use of cups surrounding the eyelids that would provide an equal distribution of heat to the eyelids and also remove any discomfort that results from compressive heat masks. The equal distribution of therapeutic heat would ensure those patients with chalazia located nasally or temporally on either the upper or lower eyelid would benefit from the treatment. Patients would also be able to blink with the use of the MantaTM Steam Mask which is beneficial for the secretion of meibum from the meibomian glands due to the muscular action of the orbicularis and Riolan's muscles. Research Questions and Hypotheses Is the use of a steam mask an effective treatment for paediatric chalazion? Does the use of a steam mask for the treatment of paediatric chalazion yield better outcomes than the use of warm compresses? Hypothesis 1 - paediatric chalazion will reduce in size or resolve with the use of a steam mask. HO 1 - paediatric chalazion will not reduce in size or resolve with the use of a steam mask. Hypothesis 2 - the use of a steam mask will be more effective than warm compresses at reducing the size or resolving paediatric chalazion. HO 2 - the use of a steam mask will not be more effective than warm compresses at reducing the size or resolving paediatric chalazion. Aims: To identify an alternative and effective treatment for paediatric chalazion, which is efficient, non-invasive and convenient. To identify the benefit of steam for the treatment of paediatric chalazion. Objectives: To identify a reduction in size or resolution of paediatric chalazion using the MantaTM Steam Mask. To identify if the use of the MantaTM Steam Mask is superior in reducing the size or resolving paediatric chalazion in comparison to warm compresses. To assess symptomatology following the use of the MantaTM Steam Mask and identify the benefits of steam in comparison to warm compresses using a questionnaire. Research Design A repeated measures ANOVA will be used to analyse data. Measurements of the chalazion will be taken for each participant on each arm of the study at each visit, comparing results from the first, second and final visit (within groups). I will then compare the data from both the steam mask group and the warm compress group (between groups). Data analysis will be performed with the statistical package for the social sciences (SPSS). The questionnaire given at each visit will include 4 questions, all using a Likert scale. Data from the questionnaire will be analysed using simple descriptive statistics. Methodology This prospective research design will identify paediatric patients within Sheffield Children's NHS Foundation Trust (SCH) that have been diagnosed with chalazion/chalazia. Diagnosis will be identified on clinical letters and patients will be collated on an excel spreadsheet. Once collated block randomisation will be used to ensure an equal chance of being chosen, reducing sampling bias. Patient notes will then be analysed for information on the below inclusion and exclusion criteria. Inclusion criteria: Diagnosed chalazion (isolated or multiple). Aged between 5 - \<16 years (reading age for participant information leaflets). A minimum head circumference of 50cm. Access to a microwave with a rotating plate. Exclusion criteria: Current or previous treatment including: triamcinolone acetonide injection and, incision and curettage. Current treatment including: oral or topical antibiotics and/or topical steroids. Other ocular co-morbidities (excluding blepharitis, meibomian gland dysfunction, and dry eye disease). Dermatological diagnoses that contraindicate the use of heat on the face. Suspicious lesion with abnormal surrounding tissue that requires further investigation. Once identified and the first visit arranged, participants will be pseudonymised and be given a unique study number to ensure confidentiality is maintained. The study number will be used for all study documentation, and all data will be saved securely on NHS password-protected computers. Any paper files will be stored securely on Trust property within the clinical research facility. Data will be collected and retained in accordance with the Data Protection Act 2018. All study documents will be retained for a period of 5 years following the end of the trial. For trial related information in the medical notes, these will be retained for 5 years after the last patient visit to the Trust. Prior to the first visit, block randomisation will be performed to ensure an equal but random distribution of participants to both the steam mask and warm compress groups. The study will consist of 3 hospital visits (SCH eye department) within an 8-week period. Following the third hospital visit, this will be the end of the study for each participant. The end of the study will be the date of the last visit for the last participant. The short questionnaire aims to subjectively assess their chalazion. If participants present with more than 1 chalazion, the surface area will be measured for the largest chalazion only. Ideally volume of chalazion would be measured, but due to difficulties obtaining this measurement, this is not feasible for the current study, and therefore the surface area of the front surface of the chalazion will be measured (π x radius2) at each visit. Reduction or resolution of the chalazion will be analysed using a 0-4 scale: 0 = no improvement or larger chalazion. 1. = 25% reduction in size. 2. = 50% reduction in size. 3. = 75% reduction in size. 4. = complete resolution. A priori analysis for a repeated measures ANOVA, with an effect size of 0.5 and a minimum power size of 0.95 would require a total of 28 participants (calculated using G\*Power 3.1). This would equal 14 participants in each group. Initial visits will be spread over 2 weeks, with a total capacity of 40 appointments (10 appointments per day for 4 days). This would be followed by 40 appointments over 2 weeks for week 4, and another 40 appointments over 2 weeks for week 8. This would account for 4 sessions per week, which is equivalent to the current job plan of an advanced clinical practitioner (ACP). Discussions with the departmental manager will be arranged to allocate time representatively, as ACP patients will still be receiving treatment as part of the study. Statistical analysis - descriptive statistics (including means, 95% confidence intervals and the range) will be collected for the measurements of the chalazion and participant questionnaires. Assuming a normal distribution, a repeated measures ANOVA will be performed to identify the mean reduction in the size of the chalazion using the MantaTM Steam Mask compared to a warm compress. Measurements will be analysed for each participant at each visit and compared within treatment groups and between treatment groups. Simple descriptive statistics will be used to analyse the data from the patient questionnaires at each visit. Safety assessments - the study visits pose very little risk for participants, with all assessments completed by appropriately trained clinical staff with Good Clinical Practice (GCP) certification. All activity will have received ethical approval and participants will receive all required information to perform treatments safely and as instructed. Treatment with the MantaTM Steam Mask and warm compresses do pose a burn risk to participants if instructions are not complied with, therefore emphasis will be made to the correct use of both treatments and information provided on what to do in case of a burn injury. Ethical considerations - all information will be made available to the participants and their parents, with age-appropriate information sheets being provided (printed or via email). Informed consent and assent will be taken prior to enrolment on the study. Following review of the notes, parents will be contacted by phone call to briefly discuss the study. If interested, information leaflets will be provided and a further phone call inviting the participant for their first visit will be made after 48 hours. Participants and parents will be informed in writing and verbally that they are free to withdraw their participation in the study at any point, even after giving consent/assent. No reason for withdrawal will be required and their future healthcare will not be compromised.

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