Motility of the Ocular Prosthesis in Anophthalmic Patients: Objective and Patient-perceived Findings.

AIM: To study the impact of the prosthesis motility on the Quality of Life (QoL) in anophthalmic patients. METHODS: Cross-sectional, observational study of 100 anophthalmic patients, of whom 64% had an acryl implant, 6% an Allen implant, 1% a hydroxyapatite implant, 4% a dermis fat graft, 16% no implant, and 9% an unknown implant. We quantitatively assessed the motility of the prosthesis with Kestenbaum glasses and the QoL with a validated questionnaire covering five domains: General functional abilities and care, wearing comfort, physical appearance, psychological and social functioning. Associations between measured prosthetic eye motility, patient-perceived motility, and satisfaction were made. RESULTS: Motility of the prosthesis was impaired with an average loss of 76%, and correlated with Cosmetic satisfaction (adduction P = .02, abduction P = .008, elevation P = .04) and Social satisfaction (adduction P = .03, abduction P = .003). The patient-perceived motility of the prosthesis correlated with General functioning abilities (horizontal P = .0004, vertical P = .0004), Comfort (horizontal P = .001, vertical P = .003), Cosmetic satisfaction (horizontal P = .0002, vertical P = .0002), Psychological satisfaction (horizontal P = .001, vertical P = .001), and Social satisfaction (horizontal P = .002, vertical P = .003). CONCLUSIONS: Ocular prosthetic motility has a significant impact on patient-perceived satisfaction and physical appearance, and predicts coping with the prosthetic condition on the psychosocial level. This highlights the need of introducing patient-reported outcome measures in the prosthetic rehabilitation of the anophthalmic patient.

Measuring quality of care and life in patients with an ocular prosthesis.

PURPOSE: In patients with an anophthalmic condition, the primary determinants of success of ocular prosthetic rehabilitation are satisfaction with care and quality of life (QoL). The aim of this study is to develop a condition-specific questionnaire as a patient-reported outcome measure for patients with an ocular prosthesis. METHODS: Observational cross-sectional prospective study. We included 100 patients (52 female, 48 male, > 18 years old) with an anophthalmic and ocular prosthetic condition existing for 2 years or more. The patients completed a pre-tested 72-item questionnaire regarding their experience on living with an ocular prosthesis in four domains of QoL: single vision and care, wearing comfort, physical appearance and motility, and psychosocial functioning. Associations with demographic factors and condition- and prosthesis-related variables were investigated with multivariate analysis. The questionnaire was reduced with principal component analysis to obtain the Global Ocular Prosthesis Score (GOPS). RESULTS: Satisfaction scores for each QoL domain were high with a mean visual analogue score between 7.2 and 7.6. Patients were generally satisfied with the physical appearance of the artificial eye and reported adequate psychosocial functioning. Patients described the reduced peripheral visual field and socket discharge as chief complaints. The test was reduced to a 20-item questionnaire. The mean GOPS was 70.87 (median 75.00). CONCLUSIONS: Patients with longstanding ocular prosthetic wear are satisfied with their physical appearance and report adequate psychosocial functioning. A concise 20-item questionnaire for the anophthalmic condition is a valuable tool to quantitatively measure patient-reported outcome of ocular prosthetic rehabilitation. TRIAL REGISTRATION NUMBER: NCT04321382, 03/2020, retrospectively registered.

The prevalence of anophthalmic socket syndrome and its relation to patient quality of life.

BACKGROUND: Following removal of the eye, soft tissue changes of the eyelids and orbit may develop into an anophthalmic socket (AS) syndrome, which is often attributed to orbital volume deficiency. While adequate primary orbital volume replacement is nowadays standard of care, patients may still present with facial asymmetry. The aim of this study is to provide insights into these changes and their impact on patient quality of life (QoL). METHODS: Cross-sectional study of 59 patients with longstanding ocular prosthetic wear after enucleation or evisceration surgery. The alignment, function, and laxity of the eyelids of the anophthalmic side were compared to those of the fellow side. The QoL was assessed with a 4-item questionnaire specific for the prosthetic condition. The different aspects of AS syndrome were analysed in relation to disease-specific and prosthetic data and to the patient QoL scores. RESULTS: Clinical AS syndrome was prevalent in 53% of patients with acquired anophthalmia. The anophthalmic side was statistically significantly different from the fellow side for the known AS syndrome features such as superior sulcus depression, margin reflex distance 1, and enophthalmia, but also for new features such as levator muscle function and lagophthalmia (P < 0.05). The difference was correlated with duration of prosthetic wear, prior orbital radiotherapy, and size of the prosthesis (P < 0.05). QoL scores were not correlated to the separate features of AS syndrome, except for a positive correlation between wearing comfort of the prosthesis and upper eyelid ptosis (P < 0.05). CONCLUSION: Patients with an ocular prosthesis show a relatively high prevalence of one or more distinct clinical features of AS syndrome, which do not negatively affect patient QoL. These findings underscore the importance to tailor prosthetic and surgical treatment to the patient's perceived QoL rather than to the objective clinical findings.

Three-dimensional design of a geometric model for an ocular prosthesis in ex vivo anophthalmic socket models.

PURPOSE: Fitting a customized ocular prosthesis for anophthalmic patients entails an artisanal labour-exhausting process and is standardly based on impression moulding of the socket, which may be anatomically inaccurate. The objective of the study was to design an impression-free socket mould with three-dimensional (3D) technology. METHODS: The ex vivo anophthalmic socket models included one silicone, one fresh pig cadaver head and three fresh-frozen human cadaver heads. After intra-socket application with iodine substance, five observers obtained eighteen low-dose cone beam computed tomography (CBCT) scans and one observer one high-dose CBCT scan of each model. The observers designed non-impression 3D moulds of the socket with 3D software. For the human cadaver sockets 3D geometric models of the ocular prosthesis were rendered from the 3D mould of the socket and the mirrored cornea of the contralateral eye. RESULTS: The posterior surface of the 3D mould was highly accurate, with a mean absolute deviation of 0.28 mm, 0.53 mm, 0.37 mm and mean upper deviation of 0.53 mm, 0.86 mm, 1.17 mm, respectively, for the phantom, pig and human model. The intra- and interobserver repeatability and reproducibility of the 3D moulds and designs was good (<0.35 mm). The largest variation in the 3D geometric model was found at the junction of the 3D mould and mirrored cornea. CONCLUSION: 3D design of an impression-free geometric model for an ocular prosthesis with low-dose CBCT is highly accurate in ex vivo anophthalmic socket models. This novel method is a critical step towards the manufacturing of 3D printed ocular prostheses and requires validation in anophthalmic patients.

Applications of three-dimensional printing in orbital diseases and disorders.

PURPOSE OF REVIEW: To comprehensively review the applications of advanced three-dimensional printing technology in the management of orbital abnormalities. RECENT FINDINGS: Three-dimensional printing has added value in the preoperative planning and manufacturing of patient-specific implants and surgical guides in the reconstruction of orbital trauma, congenital defects and tumor resection. In view of the costs and time, it is reserved as strategy for large and complex craniofacial cases, in particular those including the bony contour. There is anecdotal evidence of a benefit of three-dimensional printing in the manufacturing of prostheses for the exenterated and anophthalmic socket, and in the fabrication of patient-specific boluses, applicators and shielding devices for orbital radiation therapy. In addition, three-dimensional printed healthy and diseased orbits as phantom tangible models may augment the teaching and learning process of orbital surgery. SUMMARY: Three-dimensional printing allows precision treatment tailored to the unique orbital anatomy of the patient. Advancement in technology and further research are required to support its wider use in orbital clinical practice.

Bespoke ocular prostheses.

PURPOSE: To report the customized approach of patients with anophthalmia or microphthalmia with bespoke ocular prosthesis. METHODS: Retrospective analysis of case series. RESULTS: The study included cases with anophthalmia with upper eyelid deformity (one patient), microphthalmia and contralateral corectopia (one patient), microphthalmia with contralateral corneal graft (one patient), and congenital clinical anophthalmia with contralateral sclerocornea (one patient). Using techniques of embedded autologous hair and coating of adhesive pigment emulsion in the ocular prosthesis, the physical appearance of, respectively, an upper eyelid, corectopia, corneal graft, and sclerocornea was reproduced. CONCLUSION: Tailoring the ocular prosthesis to the distinct condition of the anophthalmic socket and contralateral eye adds to the success of rehabilitative prosthetic treatment of the patient.

Computer-aided design and three-dimensional printing in the manufacturing of an ocular prosthesis.

Restoring the facial appearance in acquired anophthalmos entails precision fitting of a customised ocular prosthesis. The fabrication is an artisanal process, and is primarily based on an impression of the anophthalmic cavity. This is usually achieved by the impression-moulding method, which, however, may introduce errors, resulting in a poorly fitted prosthesis. We developed a new method in the manufacturing of a customised ocular prosthesis based on computer-aided design and computer-aided manufacturing. An ocular prosthesis, based on a three-dimensional (3D) printed impression-free mould of the anophthalmic cavity, was successfully fitted in a 68-year-old male. To the best of our knowledge, this is the first case of a customised ocular prosthesis designed with the aid of 3D printing. TRIAL REGISTRATION NUMBER: B322201628407, Pre-results.