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NCT01264276 · ClinicalTrials.gov registry record
Telemedicine Approaches to Evaluating Acute-phase ROP
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- 269
- Enrollment target
NCT01264276 is a clinical trial that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 269 participants.
The verdict
NCT01264276 has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- 269 participants
- Enrollment target
Study Summary
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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01264276
The ClinicalTrials.gov registry entry for NCT01264276 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01264276 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01264276 about?
NCT01264276 is a clinical study titled "Telemedicine Approaches to Evaluating Acute-phase 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) crite...
What is the current status of trial NCT01264276?
This trial is currently completed. The enrollment target is 269 participants. The study started on 2011-07. Estimated completion is 2014-01.
Who is sponsoring clinical trial NCT01264276?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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