{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:48:47Z","timestamp":1777880927795,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007914","name":"University of Texas Southwestern Medical Center","doi-asserted-by":"publisher","award":["Medical Student Research Program"],"award-info":[{"award-number":["Medical Student Research Program"]}],"id":[{"id":"10.13039\/100007914","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000053","name":"National Eye Institute","doi-asserted-by":"publisher","award":["P30\/EY030413"],"award-info":[{"award-number":["P30\/EY030413"]}],"id":[{"id":"10.13039\/100000053","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","award":["UL1TR001105"],"award-info":[{"award-number":["UL1TR001105"]}],"id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["SAGE Open Medicine"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To study the effect of the COVID-19 pandemic on the early termination of ophthalmology clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>On June 10, 2022, we searched ClinicalTrials.gov and identified clinical trials pertaining to eye diseases. We included trials last updated between January 1, 2020 and June 8, 2022, as ones possibly impacted by the pandemic. We selected all interventional trials in any stage and country that were \u201crecruiting,\u201d \u201cactive, not recruiting,\u201d \u201cenrolling by invitation,\u201d \u201csuspended,\u201d \u201cterminated,\u201d \u201ccompleted,\u201d or \u201cwithdrawn\u201d and excluded trials that had been completed or discontinued before 2020, had incomplete data, trials in which the eye was not the primary focus of the trial (e.g., Chediak-Higashi syndrome, myasthenia gravis). The following trial-level characteristics were collected: location, trial status, enrollment count, ocular condition, sponsors, intervention purpose, trial phase (I\u2013IV), randomization, number of arms, and reasons for discontinuation. In addition to calculating descriptive statistics, we assessed whether trial characteristics differed between ophthalmology clinical trials canceled due to COVID-19 and those canceled for other reasons.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Following the screening, 2280\/12,679 (18%) ophthalmology clinical trials were retained. Of these, 142 (6.2%) were discontinued between January 1, 2020 and June 8, 2022. Moreover, 34 out of 142 (23.9%) ophthalmology clinical trials were discontinued due to COVID-19. These trials were more likely to be sponsored by academic medical centers (26\/34, 76.5% vs 57\/108, 52.8%, p\u2009=\u20090.03) and were not assigned to a specific study phase, indicating they were not investigational new drugs (22\/34, 64.7% vs 46\/108 42.6%, p\u2009=\u20090.003).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>COVID-19-related trial discontinuations were more likely to be reported by academic medical centers and associated with trials investigating fully approved drugs, medical devices, procedures, diagnostic imaging, and behavioral changes. Further investigation of these characteristics may lead to a more robust and resilient understanding of the causes of early termination of these clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20503121231216592","type":"journal-article","created":{"date-parts":[[2023,12,8]],"date-time":"2023-12-08T07:07:10Z","timestamp":1702019230000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov"],"prefix":"10.1177","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6998-4560","authenticated-orcid":false,"given":"Akash","family":"Kakkilaya","sequence":"first","affiliation":[{"name":"Texas A&M University School of Medicine, Bryan, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karan","family":"Hooda","sequence":"additional","affiliation":[{"name":"Texas A&M University School of Medicine, Bryan, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Praneeth","family":"Kalva","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harshith","family":"Dasara","sequence":"additional","affiliation":[{"name":"Texas A&M University School of Medicine, Bryan, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Janssen","sequence":"additional","affiliation":[{"name":"Texas A&M University School of Medicine, Bryan, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satvik","family":"Vasireddy","sequence":"additional","affiliation":[{"name":"Touro University Nevada College of Osteopathic Medicine, Henderson, NV, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arbab","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Texas A&M University School of Medicine, Bryan, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salman","family":"Khan","sequence":"additional","affiliation":[{"name":"Texas A&M University School of Medicine, Bryan, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karanjit","family":"Kooner","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA"},{"name":"Department of Ophthalmology, Veteran Affairs North Texas Health Care Medical Center, Dallas, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,12,8]]},"reference":[{"key":"bibr1-20503121231216592","unstructured":"Examination of Clinical Trial Costs and Barriers for Drug Development. ASPE, https:\/\/aspe.hhs.gov\/reports\/examination-clinical-trial-costs-barriers-drug-development-0 (accessed 24 September 2022)."},{"key":"bibr2-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-038863"},{"key":"bibr3-20503121231216592","unstructured":"ClinicalTrials.gov Background\u2014ClinicalTrials.gov, https:\/\/www.clinicaltrials.gov\/ct2\/about-site\/background (accessed 7 August 2022)."},{"key":"bibr4-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06569-2"},{"key":"bibr5-20503121231216592","unstructured":"Recommendations for urgent and nonurgent patient care. American Academy of Ophthalmology, https:\/\/www.aao.org\/headline\/new-recommendations-urgent-nonurgent-patient-care (2020, accessed 25 August 2022)."},{"key":"bibr6-20503121231216592","unstructured":"FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. FDA, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency (2020, accessed 25 August 2022)."},{"key":"bibr7-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1177\/2515841420964099"},{"key":"bibr8-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1001\/jamaophthalmol.2022.4984."},{"key":"bibr9-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2020.04.029"},{"key":"bibr10-20503121231216592","doi-asserted-by":"publisher","DOI":"10.51329\/mehdioptometry125"},{"key":"bibr11-20503121231216592","doi-asserted-by":"publisher","DOI":"10.51329\/mehdioptometry162"},{"key":"bibr12-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2019.11.004"},{"key":"bibr13-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcjo.2019.06.007"},{"key":"bibr14-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2021.04.001"},{"key":"bibr15-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61602-X"},{"key":"bibr16-20503121231216592","unstructured":"AACT Database | Clinical Trials Transformation Initiative, https:\/\/aact.ctti-clinicaltrials.org\/ (accessed 9 August 2022)."},{"key":"bibr17-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1002\/aur.2764"},{"key":"bibr18-20503121231216592","doi-asserted-by":"publisher","DOI":"10.2196\/34936"},{"key":"bibr19-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1515\/jom-2021-0278."},{"key":"bibr20-20503121231216592","unstructured":"ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies, https:\/\/prsinfo.clinicaltrials.gov\/definitions.html (accessed 10 September 2022)."},{"key":"bibr21-20503121231216592","unstructured":"Glossary of Common Site Terms\u2014ClinicalTrials.gov, https:\/\/clinicaltrials.gov\/ct2\/about-studies\/glossary (accessed 10 September 2022)."},{"key":"bibr22-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2021-052557"},{"key":"bibr23-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2022.114999"},{"key":"bibr24-20503121231216592","doi-asserted-by":"publisher","DOI":"10.1177\/03000605221093179"}],"container-title":["SAGE Open Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20503121231216592","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20503121231216592","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20503121231216592","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:26:51Z","timestamp":1777595211000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20503121231216592"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1]]},"references-count":24,"alternative-id":["10.1177\/20503121231216592"],"URL":"https:\/\/doi.org\/10.1177\/20503121231216592","relation":{},"ISSN":["2050-3121","2050-3121"],"issn-type":[{"value":"2050-3121","type":"print"},{"value":"2050-3121","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1]]},"article-number":"20503121231216592"}}