Living with an artificial eye: qualitative insights into patient and family member experiences.

PURPOSE: Artificial eye users (AEUs) can experience a negative impact on psychological and emotional wellbeing, including reduced social functioning, which may be a consequence of living with one eye removed, and/or of having a prosthetic eye. This may have wider consequences for their families. We aimed to explore what it means to live with a prosthetic eye, for both AEUs and their families-and how any quality of life (QoL) issues impact on their day-to-day functioning. METHODS: A subset of AEUs and their family members taking part in a feasibility randomised controlled trial comparing hand-painted to digitally printed artificial eyes were invited for semi-structured interviews. Transcripts were analysed using reflexive thematic analysis. Qualitative results related to trial participation are covered elsewhere. Here, we focus on QoL and day-to-day functioning. RESULTS: Twelve AEUs (eight males) and five spouses (one male) who had worn artificial eyes for 2-65 years took part, and four themes were identified. (1) Impact on day-to-day life: AEUs and their spouses have to adapt to (partial) sight loss, reduced levels of confidence, and social withdrawal. (2) Impact on psychological and emotional wellbeing: distress among AEUs and their spouses can be severe and prolonged, highlight unmet support needs. (3) Challenges with treatment experiences: AEUs experienced negative impact of fragmentation of care and long waiting times. (4) Worries about the future: AEUs mentioned fragility of remaining sight, and concerns around potential need for further treatment. CONCLUSION: Patients and their family members experience negative impact of being an AEU on their everyday lives and quality of life. There is a potential role for psychosocial support services in supporting AEUs and their families even long after eye loss.

Orbital Decompression: Conceptual Approach for Orbital Volume Expansion.

PURPOSE: To review the advances in the surgical techniques of orbital decompression. METHODS: A literature review of orbital decompression surgery and experience-based consideration of bony areas for decompression. RESULTS: In the 100-year-plus span of orbital decompression literature, multiple incisions and multiple bone and fat removal strategies have been described. In general, bone removal has been conceptualized as consisting of 4 walls of the orbit. However, the orbital bony anatomy is more subtle than a simple box, and considering 6 areas of potential bony removal allows a more nuanced paradigm for clinical decision-making and for understanding various technique descriptions. Historical and current techniques, and surgical planning and decision-making, are described from the perspective of a 6 area paradigm. Potential complications are reviewed. CONCLUSION: A conceptual framework for orbital decompression focusing on 6 potential areas of bone removal provides a nuanced and flexible paradigm for understanding and describing surgical techniques, and for designing individualized surgery. Orbital decompression surgery should be customized to the patient's anatomy and symptoms.

Orbital and Sinonasal Complications of Hydrogel Scleral Buckle: A Case Report.

The hydrogel scleral buckle is a hydrophilic implant that is characterized by progressive expansion and can present with secondary orbital changes. The authors present a unique case of hydrogel-induced erosion of the orbital roof into the frontal sinus, with formation of a sino-orbital communication that resulted in frontal sinusitis and adjacent cerebritis. The hydrogel material is radiologically characterized as a fluid-filled hypertense T2 mass with rim enhancement and peripheral calcification. Awareness of late orbital complications from the hydrogel material is important to distinguish this entity from other mimicking orbital pathologies.

Digital photographic technique for the production of an artificial eye.

The use of hand painting an iris button using oil paint remains the conventional method of artificial eye manufacturing. The authors found that replacing this technique with a digital photograph taken of a patient's unaffected eye offers several advantages over the conventional method but the process from capture to print must be standardised and colour accurate. The authors of this paper suggest a tried and tested formulated photographic process of capture and printing prior to polymerisation. It discusses issues that can arise and how these can be overcome in order to achieve a high-quality print that can be used to produce a 'life like' ocular prosthesis.

A cross-over, randomised feasibility study of digitally-printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S.

BACKGROUND/OBJECTIVES: Over 60,000 patients in the United Kingdom are estimated to have artificial eyes. Manufacturing and hand-painting of artificial eyes have not changed significantly since 1948. Delays and colour-matching issues may severely impact a patient's rehabilitation pathway. Technology advances mean alternatives are now possible. This cross-over, randomised feasibility trial aimed to determine the feasibility of conducting a full-scale trial of the effectiveness and cost-effectiveness of digitally-printed artificial eyes compared to hand-painted. SUBJECTS/METHODS: Patients aged ≥18 years who were longstanding artificial eye users requiring a replacement were randomised to receive either a hand-painted or digitally-printed eye first followed by the other type of eye. Participants were asked to approach a close contact (CC) willing to participate alongside them. A subset of participants, their CCs, and staff were interviewed about their opinions on trial procedures, artificial eyes, delivery times and satisfaction. RESULTS: Thirty-five participants were randomised and 10 CCs consented. Participant retention at final follow-up was 85.7%. Outcome data completion rates ranged from 91-100%. EQ-5D-5L completion ranged from 83-97%. Resource-use completion ranged from 0-94% with total costs at £347 for hand-painted and £404 for digitally-printed eye. There were two adverse events. Twelve participants, five CCs, and five staff were interviewed. There were positive and negative features of both types of eyes. We identified that social and psychological wellbeing is affected, often for many years after eye removal. Participation in the feasibility study was well accepted. CONCLUSIONS: The feasibility study outcomes indicate that a full trial is achievable. TRIAL REGISTRATION NUMBER: ISRCTN85921622.

Accuracy between clinical and radiological diagnoses compared to surgical orbital biopsies.

AIM: To assess the concordance between diagnosing orbital lesions by clinical examination, orbital imaging, and histological evaluation, in order to help guide future research and clinical practice. METHODS: A retrospective analysis was undertaken at a large regional tertiary referral centre of all surgical orbital biopsies performed over a 5-year period, from 1st January 2015 until 31st December 2019. Accuracy and concordance between clinical, radiological and histological diagnoses are reported as percentage sensitivity and positive predictive value. RESULTS: A total of 128 operations involving 111 patients were identified. Overall, sensitivities of 47.7% for clinical and 37.3% for radiological diagnoses were found when compared to the histological gold standard. Vascular lesions that have characteristic clinical and radiological features had the highest sensitivity at 71.4% and 57.1%, respectively. Inflammatory conditions showed the lowest sensitivity in both clinical (30.3%) and radiological (18.2%) diagnoses. The PPV for inflammatory conditions were 47.6% for clinical and 30.0% for radiological diagnoses. CONCLUSION: Accurate diagnoses are difficult to reach by relying on clinical examination and imaging alone. Surgical orbital biopsy with histological diagnosis should remain the gold standard approach for definitively identifying orbital lesions. Although larger scale prospective studies would help further refine concordance and guide future research avenues.

A cross-over, randomised feasibility study of digitally printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S - a study protocol [version 2; peer review: 2 approved].

Background/objectives: Around 11,500 artificial eyes are required yearly for new and existing patients. Artificial eyes have been manufactured and hand-painted at the National Artificial Eye Service (NAES) since 1948, in conjunction with approximately 30 local artificial eye services throughout the country. With the current scale of demand, services are under significant pressure. Manufacturing delays as well as necessary repainting to obtain adequate colour matching, may severely impact a patient's rehabilitation pathway to a normal home, social and work life. However, advances in technology mean alternatives are now possible. The aim of this study is to establish the feasibility of conducting a large-scale study of the effectiveness and cost-effectiveness of digitally printed artificial eyes compared to hand-painted eyes. Methods: A cross-over, randomised feasibility study evaluating a digitally-printed artificial eye with a hand-painted eye, in patients aged ≥18 years with a current artificial eye. Participants will be identified in clinic, via ophthalmology clinic databases and two charity websites. Qualitative interviews will be conducted in the later phases of the study and focus on opinions on trial procedures, the different artificial eyes, delivery times, and patient satisfaction. Discussion: Findings will inform the feasibility, and design, of a larger fully powered randomised controlled trial. The long-term aim is to create a more life-like artificial eye in order to improve patients' initial rehabilitation pathway, long term quality of life, and service experience. This will allow the transition of research findings into benefit to patients locally in the short term and National Health Service wide in the medium to long term._. ISRCTN registration: ISRCTN85921622 (prospectively registered on 17/06/2021).

Novel artificial eye service evaluation using patient reported outcome measures.

BACKGROUND: This service evaluation explores patient reported outcomes from patients provided with high definition ocular prostheses (artificial eyes). METHODS: Validated patient questionnaires (FACE-Q, DAS24 and HADS) were utilised to evaluate patient experiences of their new ocular prosthesis. 10 patients were included in the service evaluation, which was conducted between December 2018 and September 2019. Descriptive analysis of the mean and 95% CI was undertaken for all questionnaires. Statistical analysis was performed using SPSS 21 Principal Component Analysis (PCA) for FACE-Q questionnaires. Correlations were significant when factor loading is at α > 0.4. RESULTS: A questionnaire response rate of 80% was achieved (n = 8). PCA analysis showed the number of variables tested could be reduced. Two principal components (PC1 and PC2) had very good to excellent internal consistency between variables with factor loading (α = 0.7-0.9). PC1 contained questionnaires 1-7, all of which were highly correlated. PC2 contained question number 8 with a factor loading of α = 0.8. This indicates good reliability, validity and responsiveness. CONCLUSIONS: We hope to demonstrate the importance of service evaluations with respect to rapidly evolving technological advances in medical devices, pharmaceuticals and imaging modalities. Further feasibility and full clinical studies are required to confirm the positive results of the novel artificial eye service we have evaluated with respect to the traditional approach.

Role of ATP binding and hydrolysis in the gating of the cystic fibrosis transmembrane conductance regulator.

The CFTR gene is unique within the ATP-binding cassette (ABC) protein family, predominantly of transporters, by coding a chloride channel. The gating mechanism of ABC proteins has been characterized by the ATP Switch model in terms cycles of dimer formation and dissociation linked to ATP binding and hydrolysis, respectively. It would be of interest to assess the extent that Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), a functional channel, fits the ATP Switch model for ABC transporters. Additional transporter mechanisms, namely those of Pgp and HlyB, are discussed for perspective. Literature search of databases selected key references in comparing and contrasting the gating mechanism. CFTR is a functional chloride channel facilitating transmembrane anion flow down electrochemical gradients. A dysfunctional CFTR protein results in cystic fibrosis, a fatal pleiotropic disease currently managed symptomatically. Understanding the gating mechanism will help target drug development aimed at alleviating and curing the disease.

Lower gastrointestinal perforation in rheumatoid arthritis patients treated with conventional DMARDs or tocilizumab: a systematic literature review.

Tocilizumab, a monoclonal antibody targeting the IL-6 receptor, has recently been added to the therapeutic armamentarium against rheumatoid arthritis (RA). Despite its overall safety, concerns have been raised regarding diverticular perforation in patients receiving the drug. The aim of our research was to document the incidence of diverticular disease in RA patients treated in the pre-disease-modifying anti-rheumatic drug (DMARD) era, following treatment with conventional DMARDs, and subsequent to tocilizumab therapy. We performed a systematic literature review in MEDLINE, EMBASE, Conference Proceedings Citation Index-Science, Cochrane Central Register of Controlled Trials and Current Controlled Trials up to Nov. 2010. The publication titles and abstracts were independently assessed by two reviewers for relevance and quality, and the review was conducted following guidelines from the Centre for Reviews and Dissemination. In the pre-DMARD period of RA management, where patients were largely treated with NSAIDs and corticosteroids, gastrointestinal (GI) complications were a substantial cause of mortality with diverticulitis and colonic ulcers accounting for almost a third of GI-related deaths. In contrast, our search did not reveal any evidence of diverticular perforation in patients treated with conventional DMARDs. Eighteen cases of lower GI perforation (16 of whom had diverticulitis) have been documented in recent conference proceedings following tocilizumab treatment in clinical trials, with a lower GI perforation rate of 1.9 per 1,000 patient years (PY). This lies between the reported rate of GI perforations for corticosteroids and anti-TNF-α agents in the United Health Care database, with rates of 3.9 per 1,000 PY (95% CI 3.1-4.8) and 1.3 per 1,000 PY (95% CI 0.8-1.9), respectively. The majority of these patients were concurrently prescribed NSAIDs and/or long-term corticosteroids. Traditional DMARD therapy for RA appears not only to have modified the risk of lower GI perforation but prevented it. The risk of diverticular perforation may be slightly higher in patients treated with tocilizumab compared with conventional DMARDs or anti-TNF agents, but lower than that for corticosteroids. The mechanism of action of IL-6 antagonism in the pathophysiology of diverticular perforation has yet to be elucidated.