Retinopathy of PrematurityNCT01335113
A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
An observational study of Retinopathy of Prematurity, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to 1 Oct 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature newborns who are screened for retinopathy of prematurity at Stanford
Who may be able to join
- neonates being screened for retinopathy of prematurity
Who cannot join
- medically unstable neonates
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity.
- Conditions
- Retinopathy of Prematurity
- Medical subject headings
- Retinopathy of Prematurity
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length
axial length as measured by a scan ulstrasonography
Measured: one year
Secondary outcomes (2)
anterior corneal curvature
anterior corneal curvature as measured by keratometer
Measured: one year
wide angle fundus photography
wide angle fundus photography by RetCam camera
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startOct 2010
- Primary completion1 Oct 2015
- Study completion1 Oct 2015
Why it stopped: Unable to get accurate measurements with existing technology
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 Stanford UniversityThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Principal investigator, Darius M. Moshfeghi, Stanford University
- Investigators
- Darius M Moshfeghi, MD, Study director, Stanford UniversityDarius Moshfeghi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335113
- Sponsor's protocol ID
- 19891
- Status last verified
- Jul 2020
- First submitted
- 1 Apr 2011
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT01335113
- Acronym / sponsor ID
- 19891
- Conditions
- Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to get accurate measurements with existing technology
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Oct 2010
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Oct 2015 (actual)
- First posted
- 14 Apr 2011 (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.
The purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature newborns who are screened for retinopathy of prematurity at Stanford
Key inclusion criteria (1 listed)
- neonates being screened for retinopathy of prematurity
Key exclusion criteria (1 listed)
- medically unstable neonates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
axial length
Time frame: one year
axial length as measured by a scan ulstrasonography
2 secondary outcomes
anterior corneal curvature
Time frame: one year
wide angle fundus photography
Time frame: one year
Results and safety
The study was stopped early (reason given: Unable to get accurate measurements with existing technology). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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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.
Darius M Moshfeghi, MD study director
Stanford University
Darius Moshfeghi, MD principal investigator
Stanford University
1 site 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 Stanford University at 1 site 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 1 inclusion and 1 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Unable to get accurate measurements with existing technology). 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?
axial length (time frame: one year). 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 9 Jul 2020.