Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP)
The primary objective of this multi-center clinical study is to evaluate the validity, reliability, feasibility, safety and relative cost-effectiveness of a retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies who meet referral warranted ROP (RW-ROP) criteria and therefore need a diagnostic evaluation by an ophthalmologist experienced in ROP.
We shall:
- Calculate the accuracy, using sensitivity and specificity, of the system to provide remote evaluations when compared with the findings of a "gold standard" indirect ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously trained in ROP diagnostic examinations (validity);
- Determine intra-reader and inter-reader agreement for deciding whether digital images indicate that the eyes of a baby are in need of diagnostic indirect ophthalmoscopy by an ophthalmologist experienced in ROP (reliability);
- Determine whether imaging evaluation can be achieved for each baby (feasibility);
- Examine ocular and systemic complications associated with digital imaging and compared with those associated with diagnostic examinations performed by an ophthalmologist (safety);
- Compare the costs and benefits of adopting a telemedicine retinal imaging system compared to the current cost of indirect ophthalmoscopic examinations (cost-effectiveness).
Visão geral do estudo
Status
Condições
Descrição detalhada
Eligibility Criteria:
• Babies with birth weights of <1251 grams(g) at selected large clinical centers in the US and Canada.
Procedures:
• Participants will undergo both digital retinal imaging and clinically indicated indirect ophthalmoscopic examinations on the same day. Wide-field digital images (WF-DI) of both eyes will be captured by non-physician Certified ROP Imagers (CRIs) using standardized imaging protocols. The RetCam Shuttle® (Clarity Medical Systems, Pleasanton, CA), a corneal-contact camera that captures wide field (130 degree field of view) retinal images, will be used.
Masking:
• Study-certified Ophthalmologist and Study-certified Imager at the clinical sites will be masked to each other's findings. The Study Clinical Coordinator (SCC) will remain unmasked. SCC will monitor the clinical noteworthy events and report all adverse events to the site Institutional Review Board (IRB), the Project Director at the Office of Study Chair, and to the Data Coordinating Center (DCC). DCC will prepare closed-session Data Monitoring and Oversight Committee (DMOC) reports. The PI at each site will monitor adverse events.
Outcome Measures:
• The primary outcome measure is detection of referral warranted ROP (RW-ROP) on digital images. Retinal images will be graded by Trained Readers using a standardized protocol to identify eyes with RW-ROP. Results of the gradings will be compared to the diagnostic examinations being performed on each child at the same session when images taken. For comparison, images will also be graded by ROP experts (Expert Readers).
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N 1N4
- University Of Calgary
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- University of Louisville
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital Boston
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University
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Ohio
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Columbus, Ohio, Estados Unidos, 43205
- Nationwide Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas San Antonio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Babies with birth weighs of <1251g at selected large clinical centers in the US and Canada.
- Admitted to a participating Neonatal Intensive Care Units (NICU) and expected to survive to 28 days.
- Likely to remain in participating NICU for serial ROP exams.
- Transferred to participating NICU for treatment of ROP (regardless of PMA).
- Parents or guardians have provided informed consent for participation in the study.
Exclusion Criteria:
- Failure to obtain informed consent.
- Known ocular anomalies that prevent imaging of the retina.
- Life threatening anomalies (i.e. heart, neurological, etc).
- Admission to participating NICU with ROP that is already regressing or treated.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Detection of Referral Warranted ROP
Prazo: 6 weeks
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Graham E Quinn, MD, MSCE, Children's Hospital of Philadelphia
Publicações e links úteis
Publicações Gerais
- Wade KC, Ying GS, Baumritter A, Gong A, Kemper AR, Quinn GE; e-ROP Cooperative Group. Factors in Premature Infants Associated With Low Risk of Developing Retinopathy of Prematurity. JAMA Ophthalmol. 2019 Feb 1;137(2):160-166. doi: 10.1001/jamaophthalmol.2018.5520.
- Quinn GE, Ying GS, Repka MX, Siatkowski RM, Hoffman R, Mills MD, Morrison D, Daniel E, Baumritter A, Hildebrand PL, Schron EB, Ells AL, Wade K, Kemper AR. Timely implementation of a retinopathy of prematurity telemedicine system. J AAPOS. 2016 Oct;20(5):425-430.e1. doi: 10.1016/j.jaapos.2016.06.007. Epub 2016 Sep 17.
- Morrison D, Bothun ED, Ying GS, Daniel E, Baumritter A, Quinn G; e-ROP Cooperative Group. Impact of number and quality of retinal images in a telemedicine screening program for ROP: results from the e-ROP study. J AAPOS. 2016 Dec;20(6):481-485. doi: 10.1016/j.jaapos.2016.08.004. Epub 2016 Oct 1.
- Kemper AR, Prosser LA, Wade KC, Repka MX, Ying GS, Baumritter A, Quinn GE; e-ROP Study Cooperative Group. A Comparison of Strategies for Retinopathy of Prematurity Detection. Pediatrics. 2016 Jan;137(1):e20152256. doi: 10.1542/peds.2015-2256. Epub 2015 Dec 15.
- Wade KC, Pistilli M, Baumritter A, Karp K, Gong A, Kemper AR, Ying GS, Quinn G; e-Retinopathy of Prematurity Study Cooperative Group. Safety of Retinopathy of Prematurity Examination and Imaging in Premature Infants. J Pediatr. 2015 Nov;167(5):994-1000.e2. doi: 10.1016/j.jpeds.2015.07.050. Epub 2015 Aug 20.
- Kemper AR, Wade KC, Hornik CP, Ying GS, Baumritter A, Quinn GE; Telemedicine Approaches to Evaluating Acute-phase Retinopathy of Prematurity (e-ROP) Study Cooperative Group. Retinopathy of prematurity risk prediction for infants with birth weight less than 1251 grams. J Pediatr. 2015 Feb;166(2):257-61.e2. doi: 10.1016/j.jpeds.2014.09.069. Epub 2014 Nov 12.
- Quinn GE, Ying GS, Daniel E, Hildebrand PL, Ells A, Baumritter A, Kemper AR, Schron EB, Wade K; e-ROP Cooperative Group. Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity. JAMA Ophthalmol. 2014 Oct;132(10):1178-84. doi: 10.1001/jamaophthalmol.2014.1604.
- Graham E Quinn; e-ROP Cooperative Group. Telemedicine approaches to evaluating acute-phase retinopathy of prematurity: study design. Ophthalmic Epidemiol. 2014 Aug;21(4):256-67. doi: 10.3109/09286586.2014.926940. Epub 2014 Jun 23.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10-007554
- U10EY017014-01A2 (Concessão/Contrato do NIH dos EUA)
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