{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T05:01:52Z","timestamp":1771477312284,"version":"3.50.1"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"17","license":[{"start":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T00:00:00Z","timestamp":1722556800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T00:00:00Z","timestamp":1722556800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009128","name":"DH | NIHR | Research for Patient Benefit Programme","doi-asserted-by":"publisher","award":["NIHR201559"],"award-info":[{"award-number":["NIHR201559"]}],"id":[{"id":"10.13039\/501100009128","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eye"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background\/objectives<\/jats:title>\n                <jats:p>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\u2019s 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Subjects\/methods<\/jats:title>\n                <jats:p>Patients aged \u226518 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>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\u2013100%. EQ-5D-5L completion ranged from 83\u201397%. Resource-use completion ranged from 0\u201394% with total costs at \u00a3347 for hand-painted and \u00a3404 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>The feasibility study outcomes indicate that a full trial is achievable.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration number<\/jats:title>\n                <jats:p>ISRCTN85921622.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1038\/s41433-024-03273-0","type":"journal-article","created":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T18:02:27Z","timestamp":1722621747000},"page":"3263-3271","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A cross-over, randomised feasibility study of digitally-printed versus hand-painted artificial eyes in adults: PERSONAL-EYE-S"],"prefix":"10.1038","volume":"38","author":[{"given":"Amie","family":"Woodward","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Coleman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Ronaldson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tim","family":"Zoltie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Bartlett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Wilson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom","family":"Archer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Kawalek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florien","family":"Boele","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"Chang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Kalantzis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mike","family":"Theaker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nabil","family":"El-Hindy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Walshaw","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taras","family":"Gout","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0694-3854","authenticated-orcid":false,"given":"Judith","family":"Watson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,8,2]]},"reference":[{"key":"3273_CR1","doi-asserted-by":"publisher","first-page":"616","DOI":"10.1136\/bjo.2006.103937","volume":"91","author":"P Viswanathan","year":"2007","unstructured":"Viswanathan P, Sagoo MS, Olver JM. UK national survey of enucleation, evisceration and orbital implant trends. Br J Ophthalmol. 2007;91:616\u20139.","journal-title":"Br J Ophthalmol"},{"key":"3273_CR2","doi-asserted-by":"publisher","first-page":"330","DOI":"10.1007\/s00417-005-0037-0","volume":"244","author":"JS Song","year":"2006","unstructured":"Song JS, Oh J, Baek SH. A survey of satisfaction in an ophthalmic patients wearing ocular prosthesis. Graefes Arch Clin Exp Ophthalmol. 2006;244:330\u20135.","journal-title":"Graefes Arch Clin Exp Ophthalmol"},{"key":"3273_CR3","first-page":"259","volume":"8","author":"V Lubkin","year":"1990","unstructured":"Lubkin V, Sloan S. Enucleation and psychic trauma. Adv Ophthalmic Plast Reconstr Surg. 1990;8:259\u201362.","journal-title":"Adv Ophthalmic Plast Reconstr Surg"},{"key":"3273_CR4","doi-asserted-by":"publisher","first-page":"39","DOI":"10.3109\/01676830.2013.851251","volume":"33","author":"HB McBain","year":"2014","unstructured":"McBain HB, Ezra DG, Rose GE, Newman SP. The psychosocial impact of living with an ocular prosthesis. Orbit. 2014;33:39\u201344.","journal-title":"Orbit"},{"issue":"Apr","key":"3273_CR5","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1080\/17453054.2021.1882294","volume":"44","author":"T Zoltie","year":"2021","unstructured":"Zoltie T, Bartlett P, Archer T, Walshaw E, Gout T. Digital photographic technique for the production of an artificial eye. J Vis Commun Med. 2021;44(Apr):41\u20134. https:\/\/doi.org\/10.1080\/17453054.2021.1882294.","journal-title":"J Vis Commun Med"},{"key":"3273_CR6","first-page":"25","volume":"8","author":"L Cerullo","year":"1990","unstructured":"Cerullo L. Plastic artificial eyes: overview and technique. Adv Ophthalmic Plast Reconstr Surg. 1990;8:25\u201345.","journal-title":"Adv Ophthalmic Plast Reconstr Surg"},{"key":"3273_CR7","doi-asserted-by":"publisher","first-page":"50","DOI":"10.3310\/nihropenres.13311.2","volume":"2","author":"T Gout","year":"2023","unstructured":"Gout T, Zoltie T, Woodward A, Coleman E, Boele F, Chang B, et al. 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]. NIHR Open Res. 2023;2:50.","journal-title":"NIHR Open Res"},{"key":"3273_CR8","doi-asserted-by":"publisher","first-page":"i5239","DOI":"10.1136\/bmj.i5239","volume":"355","author":"SM Eldridge","year":"2016","unstructured":"Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.","journal-title":"BMJ"},{"key":"3273_CR9","doi-asserted-by":"publisher","first-page":"l4378","DOI":"10.1136\/bmj.l4378","volume":"366","author":"K Dwan","year":"2019","unstructured":"Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019;366:l4378.","journal-title":"BMJ"},{"key":"3273_CR10","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-15-264","volume":"15","author":"MD Teare","year":"2014","unstructured":"Teare MD, Dimairio M, Shephard N, Hayman A, Whitehead A, Walters S. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials 2014;15:264.","journal-title":"Trials"},{"key":"3273_CR11","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1002\/pst.185","volume":"4","author":"SA Julious","year":"2005","unstructured":"Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4:287\u201391.","journal-title":"Pharm Stat"},{"key":"3273_CR12","doi-asserted-by":"publisher","first-page":"227","DOI":"10.1007\/s10792-024-02933-0","volume":"44","author":"FW Boele","year":"2024","unstructured":"Boele FW, Kawalek JC, Nicklin E, Gout T, Watson JM. on behalf of The PERSONAL-EYE-S Study Group. Living with an artificial eye: qualitative insights into patient and family member experiences. Int Ophthalmol. 2024;44:227. https:\/\/doi.org\/10.1007\/s10792-024-02933-0.","journal-title":"Int Ophthalmol"},{"key":"3273_CR13","volume-title":"Briefing notes for researchers: involving the public in NHS, public health and social care research","author":"INVOLVE.","year":"2012","unstructured":"INVOLVE. Briefing notes for researchers: involving the public in NHS, public health and social care research. Eastleigh: INVOLVE; 2012."}],"container-title":["Eye"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41433-024-03273-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41433-024-03273-0","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41433-024-03273-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T11:04:09Z","timestamp":1732273449000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41433-024-03273-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,2]]},"references-count":13,"journal-issue":{"issue":"17","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["3273"],"URL":"https:\/\/doi.org\/10.1038\/s41433-024-03273-0","relation":{},"ISSN":["0950-222X","1476-5454"],"issn-type":[{"value":"0950-222X","type":"print"},{"value":"1476-5454","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,2]]},"assertion":[{"value":"12 September 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 July 2024","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 July 2024","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 August 2024","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This project was funded by the National Institute for Health and Care\u00a0Research (NIHR) under its Research for Patient Benefit (RfPB) Programme [Grant Reference Number NIHR201559]. All authors, with the exception of MT, have a proportion of their salaries covered by the research funding received.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Ethical approval was granted by North West\u2014Haydock on 09th June 2021 (Reference 21\/NW\/0150). The trial has been registered on ISRCTN (registration number: ISRCTN85921622) on 17th June 2021.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}