Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP)
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Purpose
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).
| Condition |
|---|
|
Retinopathy of Prematurity |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Telemedicine Approaches to Evaluating Acute-phase ROP |
- Detection of Referral Warranted ROP [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 32 Weeks to 40 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Babies with birth weighs of <1251g at selected large clinical centers in the US
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.
Contacts and Locations| Contact: Agnieshka Baumritter, MS | 215 590 4956 | baumritter@email.chop.edu |
| United States, Kentucky | |
| University of Louisville | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Charles C Barr, MD 502-852-5466 Charles.barr@louisville.edu | |
| Principal Investigator: Charles C Barr, MD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Michael X Repka, MD 410-955-8314 mrepka@jhmi.edu | |
| Principal Investigator: Michael X Repka, MD | |
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Deborah VanderVeen, MD 617-355-8531 Deborah.Vanderveen@childrens.harvard.edu | |
| Principal Investigator: Deborah Vanderveen, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Eric D Bothun, MD 612-625-4400 Bothu003@umn.edu | |
| Principal Investigator: Eric D Bothun, MD | |
| United States, North Carolina | |
| Duke University | Completed |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Don L Bremer, MD 614-722-6129 Don.bremer@nationwidechildrens.org | |
| Principal Investigator: Don L Bremer, MD | |
| United States, Oklahoma | |
| University of Oklahoma | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Michael Siatkowski, MD 405-271-1094 RMichael-Siatkowski@dmei.org | |
| Principal Investigator: Michael Siatkowski, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Karen A Karp, BSN 215-590-7003 karpk@email.chop.edu | |
| Principal Investigator: Monte Mills, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: David Morrison, MD 615-936-1035 david.morrison.1@vanderbilt.edu | |
| Principal Investigator: David Morrison, MD | |
| United States, Texas | |
| University of Texas San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Alice Gong, MD 210-567-5227 gong@uthschsa.edu | |
| Principal Investigator: Alice Gong, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Robert Hoffman, MD robert.hoffman@hsc.utah.edu | |
| Principal Investigator: Robert Hoffman, MD | |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Contact: Anna Ells, MD 403-245-4205 annaells@me.com | |
| Principal Investigator: Anna Ells, MD | |
| Principal Investigator: | Graham E Quinn, MD, MSCE | Children's Hospital of Philadelphia |
More Information
No publications provided
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT01264276 History of Changes |
| Other Study ID Numbers: | 10-007554, U10EY017014-01A2 |
| Study First Received: | December 20, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Children's Hospital of Philadelphia:
|
ROP Retinopathy of Prematurity Telemedicine |
Additional relevant MeSH terms:
|
Retinal Diseases Retinopathy of Prematurity Eye Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 21, 2013