Telemedicine Approaches to Evaluating Acute-phase ROP
Public ClinicalTrials.gov record NCT01264276. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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: 1. 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); 2. 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); 3. Determine whether imaging evaluation can be achieved for each baby (feasibility); 4. Examine ocular and systemic complications associated with digital imaging and compared with those associated with diagnostic examinations performed by an ophthalmologist (safety); 5. Compare the costs and benefits of adopting a telemedicine retinal imaging system compared to the current cost of indirect ophthalmoscopic examinations (cost-effectiveness).
Study identification
- NCT ID
- NCT01264276
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 269 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 32 Weeks to 40 Weeks
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2011 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Jan 2014 (Actual)
- Last update posted
- Feb 4, 2015
2011 – 2014
United States locations
- U.S. sites
- 11
- U.S. states
- 11
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| University of Texas San Antonio | San Antonio | Texas | 78229 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01264276, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2015 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01264276 live on ClinicalTrials.gov.