Retinopathy of PrematurityNCT02257307
Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project
An observational study of Retinopathy of Prematurity, run by Children's Hospital of Philadelphia at 5 sites in United States.
Trial summary
Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the… Read more about this study
- Who is it for?
- Ages 32 to 40 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- RetCam retinal imaging used for routine care
- Type of treatment
- Surgery or procedure
- How many people
- 244 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2014to 16 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature babies (N=500) with birth weights of <1251g who meet current ROP screening guidelines in 5 NICUs in US.
Who may be able to join
- Babies with birth weights of <1251g
- Babies having clinical examinations to screen for ROP
Who cannot join
- Referral from an outside hospital for treatment of serious ROP that is performed before imaging can be obtained.
- Congenital Non-ocular Anomalies: Babies will be excluded from this study if they have a severe congenital non-ocular anomaly. Such exclusions include anencephaly, trisomy 13, trisomy 18, or severe cardiac or pulmonary abnormalities. The neonatologist caring for the baby will determine whether a particular congenital abnormality would exclude the baby from participation in this study.
- Ocular Abnormalities: Babies will be excluded from this study if they have major congenital abnormalities in one or both eyes including microphthalmos, anophthalmos, anterior segment dysgenesis, dense corneal opacity, cataract, glaucoma, chorioretinitis, optic nerve hypoplasia, and chorioretinal coloboma. Eyelid abnormalities, such as severe blepharoptosis or severe hemangioma, that would likely affect vision, would also exclude a baby from participation. Minor abnormalities that would not be expected to affect vision may not be exclusion criteria including Mittendorf dot, mild blepharoptosis, limbal dermoid, and iris coloboma.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Vanderbilt University
Nashville, Tennessee, 37232
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Ancillary Study - Implementation Project
Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical Center.
Read the detailed description
Study Design: Observational Cohort Study Setting/Participants: Premature babies who are at high risk for ROP during their stay in the neonatal intensive care unit (NICU).
- The number of sites - 5 centers in the US
- The number and description of participants: 500 babies with birth weights of <1251g
Study Interventions and Measures:
Data from RetCam digital images obtained as part of clinical care during the routine diagnostic eye exam for ROP will be uploaded and transmitted via secure server to a central reading center. These de-identified images will be graded by Certified Image Readers. Results of image gradings will be sent back via secure web-based platform to the Clinical Center. The primary outcome measure is the turnaround time from uploading the images to feedback to the Clinical Center. The secondary outcome measure is the time required to obtain retinal images for babies scheduled for ROP examination in the NICU (relative cost-effectiveness).
- Conditions
- Retinopathy of Prematurity
- Being tested
- RetCam retinal imaging used for routine care
- Keywords
- ROP, retinopathy, Referral warranted retinopathy
- Medical subject headings
- Retinopathy of Prematurity, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetCam retinal imaging used for routine careProcedure or surgery
De-identified digital images of both eyes, obtained by a non-physician Certified ROP Imager (CRI) using the RetCam Shuttle, will be uploaded to the secure server for remote evaluation by a Trained Reader. The results of the Reader's evaluation will be reported to the Clinical Center.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether imaging evaluation can be achieved for each baby within 24 hours following uploading of images in order to provide timely feedback to the examining ophthalmologist.
Interval from uploading the images to the secure server to the time a grading report is submitted to the Clinical Center
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completion16 Mar 2016
Why it stopped: expired study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Graham E Quinn, MD, MSCE, Study chair, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257307
- Sponsor's protocol ID
- 14-010824
- Other IDs
- U10EY017014
- Status last verified
- Apr 2017
- First submitted
- 2 Oct 2014
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Ancillary Study - Implementation Project
- ClinicalTrials.gov ID
- NCT02257307
- Acronym / sponsor ID
- 14-010824
- Conditions
- Retinopathy of Prematurity
- Keywords
- ROP, retinopathy, Referral warranted retinopathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: expired study
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- 16 Mar 2016 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical Center.
Detailed description
Study Design: Observational Cohort Study Setting/Participants: Premature babies who are at high risk for ROP during their stay in the neonatal intensive care unit (NICU).
- The number of sites - 5 centers in the US
- The number and description of participants: 500 babies with birth weights of <1251g
Study Interventions and Measures:
Data from RetCam digital images obtained as part of clinical care during the routine diagnostic eye exam for ROP will be uploaded and transmitted via secure server to a central reading center. These de-identified images will be graded by Certified Image Readers. Results of image gradings will be sent back via secure web-based platform to the Clinical Center. The primary outcome measure is the turnaround time from uploading the images to feedback to the Clinical Center. The secondary outcome measure is the time required to obtain retinal images for babies scheduled for ROP examination in the NICU (relative cost-effectiveness).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 32 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature babies (N=500) with birth weights of <1251g who meet current ROP screening guidelines in 5 NICUs in US.
Key inclusion criteria (2 listed)
- Babies with birth weights of <1251g
- Babies having clinical examinations to screen for ROP
Key exclusion criteria (3 listed)
- Referral from an outside hospital for treatment of serious ROP that is performed before imaging can be obtained.
- Congenital Non-ocular Anomalies: Babies will be excluded from this study if they have a severe congenital non-ocular anomaly. Such exclusions include anencephaly, trisomy 13, trisomy 18, or severe cardiac or pulmonary abnormalities. The neonatologist caring for the baby will determine whether a particular congenital abnormality would exclude the baby from participation in this study.
- Ocular Abnormalities: Babies will be excluded from this study if they have major congenital abnormalities in one or both eyes including microphthalmos, anophthalmos, anterior segment dysgenesis, dense corneal opacity, cataract, glaucoma, chorioretinitis, optic nerve hypoplasia, and chorioretinal coloboma. Eyelid abnormalities, such as severe blepharoptosis or severe hemangioma, that would likely affect vision, would also exclude a baby from participation. Minor abnormalities that would not be expected to affect vision may not be exclusion criteria including Mittendorf dot, mild blepharoptosis, limbal dermoid, and iris coloboma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetCam retinal imaging used for routine careDe-identified digital images of both eyes, obtained by a non-physician Certified ROP Imager (CRI) using the RetCam Shuttle, will be uploaded to the secure server for remote evaluation by a Trained Reader. The results of the Reader's evaluation will be reported to the Clinical Center. | Procedure or surgery | – |
Primary outcome
Determine whether imaging evaluation can be achieved for each baby within 24 hours following uploading of images in order to provide timely feedback to the examining ophthalmologist.
Time frame: 6 months
Interval from uploading the images to the secure server to the time a grading report is submitted to the Clinical Center
Results and safety
The study was stopped early (reason given: expired study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Related trials for Retinopathy of Prematurity
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham E Quinn, MD, MSCE study chair
Children's Hospital of Philadelphia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Children's Hospital of Philadelphia at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: expired study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether imaging evaluation can be achieved for each baby within 24 hours following uploading of images in order to provide timely feedback to the examining ophthalmologist. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.