Retinopathy of Prematurity (ROP)NCT01054027
Study on Effective Mydriasis in Premature Infants
A study testing 1% phenylephrine and 0.2% cyclopentolate in people with Retinopathy of Prematurity (ROP), run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening exams for Retinopathy of Prematurity (ROP). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- 1% phenylephrine and 0.2% cyclopentolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2008
- Phase
- Interventional
- 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
Who may be able to join
- Premature infants undergoing clinically indicated retinal exams
Who cannot join
- Ocular congenital anomalies
- Pre-threshold ROP
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized Controlled Trial to Determine the Lowest Effective Dose for Adequate Mydriasis in Premature Infants
The purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening exams for Retinopathy of Prematurity (ROP).
Read the detailed description
Premature infants need to have eye exams starting at about 4 weeks of age and continuing until their retinas (membrane at the back of the eye which collects and transfers light) is fully grown. These exams are done to see if they have developed ROP, a disease which can lead to blindness if not treated.
The ophthalmologist (eye doctor) looks through the enlarged pupil (opening at the front of the eye) to see the retina. The drug that is used to dilate the pupil, Cyclomydril, has been shown to have side effects in premature infants. No literature has shown what the optimal dose is for premature babies. Nursery policy is to give 3 drops of Cyclomydril in each eye, at 5 minute intervals, 45-60 minutes before a scheduled eye exam. We sought to reduce the dose without delaying the exam for an under-sized pupil.
In the study, each infant is randomized at the time of the exam to receive either 0, 1 or 2 drops of Cyclomydril in the left eye and 3 drops in the right eye to serve as their own control. The zero-drop group was created to test the contralateral (opposite eye) effect of 3 drops in the right eye. Pupil dilation size is measured using the Colvard pupillometer by a Pediatric Ophthalmologist examiner (G.V.V.) who was not masked to study group assignment.
Measures of pupil size are done at baseline (before any drops given), 45, 90 and 120 minutes after the first drop was given. ROP screening exam is done at the first opportunity to visualize the posterior and peripheral retina.
Additional drops are given at 120 minutes if the observer is unable to complete the exam prior to that point.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- 1% phenylephrine and 0.2% cyclopentolate
- Keywords
- Retinopathy of Prematurity (ROP), Eye exams, Premature infants, cyclomydril
- Medical subject headings
- Retinopathy of Prematurity, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% phenylephrine and 0.2% cyclopentolateDrug
Also called Cyclomydril
given as drops, prior to eye exam
| Study group | Role | What they receive |
|---|---|---|
| 0 Drop | Experimental | Left eye dose Receives: Drug: 1% phenylephrine and 0.2% cyclopentolate |
| 1 Drop | Experimental | Left eye dose Receives: Drug: 1% phenylephrine and 0.2% cyclopentolate |
| 2 drop | Experimental | Left eye dose Receives: Drug: 1% phenylephrine and 0.2% cyclopentolate |
| 3 drops | Active comparator | Right eye dose for all groups Receives: Drug: 1% phenylephrine and 0.2% cyclopentolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
dilation of the pupil in millimeters
Measured: at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMar 2007
- Primary completionNov 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by Georgetown 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Investigators
- Monisha Bahri, MD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054027
- Sponsor's protocol ID
- 2007-109
- Status last verified
- Jan 2010
- First submitted
- 21 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Determine the Lowest Effective Dose for Adequate Mydriasis in Premature Infants
- ClinicalTrials.gov ID
- NCT01054027
- Acronym / sponsor ID
- 2007-109
- Conditions
- Retinopathy of Prematurity (ROP)
- Keywords
- Retinopathy of Prematurity (ROP), Eye exams, Premature infants, cyclomydril
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Jan 2010 (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 this study is to compare the dilating effect of 0, 1, 2 or 3 drops of mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening exams for Retinopathy of Prematurity (ROP).
Detailed description
Premature infants need to have eye exams starting at about 4 weeks of age and continuing until their retinas (membrane at the back of the eye which collects and transfers light) is fully grown. These exams are done to see if they have developed ROP, a disease which can lead to blindness if not treated.
The ophthalmologist (eye doctor) looks through the enlarged pupil (opening at the front of the eye) to see the retina. The drug that is used to dilate the pupil, Cyclomydril, has been shown to have side effects in premature infants. No literature has shown what the optimal dose is for premature babies. Nursery policy is to give 3 drops of Cyclomydril in each eye, at 5 minute intervals, 45-60 minutes before a scheduled eye exam. We sought to reduce the dose without delaying the exam for an under-sized pupil.
In the study, each infant is randomized at the time of the exam to receive either 0, 1 or 2 drops of Cyclomydril in the left eye and 3 drops in the right eye to serve as their own control. The zero-drop group was created to test the contralateral (opposite eye) effect of 3 drops in the right eye. Pupil dilation size is measured using the Colvard pupillometer by a Pediatric Ophthalmologist examiner (G.V.V.) who was not masked to study group assignment.
Measures of pupil size are done at baseline (before any drops given), 45, 90 and 120 minutes after the first drop was given. ROP screening exam is done at the first opportunity to visualize the posterior and peripheral retina.
Additional drops are given at 120 minutes if the observer is unable to complete the exam prior to that point.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 Drop | Experimental | Drug: 1% phenylephrine and 0.2% cyclopentolateLeft eye dose |
| 1 Drop | Experimental | Drug: 1% phenylephrine and 0.2% cyclopentolateLeft eye dose |
| 2 drop | Experimental | Drug: 1% phenylephrine and 0.2% cyclopentolateLeft eye dose |
| 3 drops | Active comparator | Drug: 1% phenylephrine and 0.2% cyclopentolateRight eye dose for all groups |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Premature infants undergoing clinically indicated retinal exams
Key exclusion criteria (2 listed)
- Ocular congenital anomalies
- Pre-threshold ROP
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 |
|---|---|---|
| 1% phenylephrine and 0.2% cyclopentolateAlso: Cyclomydrilgiven as drops, prior to eye exam | Drug | 0 Drop, 1 Drop, 2 drop, 3 drops |
Primary outcome
dilation of the pupil in millimeters
Time frame: at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
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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.
Monisha Bahri, MD principal investigator
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1% phenylephrine and 0.2% cyclopentolate in people with Retinopathy of Prematurity (ROP), run by Georgetown 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 2 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: finished, as of the sponsor's last update on 22 Jan 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dilation of the pupil in millimeters (time frame: at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled). 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 22 Jan 2010.