Preterm InfantsPhase 4NCT00877175
Comparison of Instillation and Packing in Mydriasis for Premature Infants
A Phase 4 study testing 1% tropicamide and 2.5% phenylephrine in people with Preterm Infants, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants. Read more about this study
- Who is it for?
- Ages 1 month to 4 months
- Conditions the study is for
- Preterm Infants
- What is being tested?
- 1% tropicamide and 2.5% phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2009to Jun 2009
- Phase
- Phase 4
- 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 1 month to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams
- stable clinical course
Who cannot join
- history of intraocular surgery or laser treatment
- previous eyedrop instillation that might affect the pupil size
- severe underlying disease or unstable clinical course that mydriatic drugs or the examination could aggravate their conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants
The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.
Read the detailed description
Adequate pupil dilatation was needed for screening and treatment of retinopathy of prematurity (ROP) in premature infants.In general clinical practice, mydriatic drugs were instilled many times until the pupil reached the maximum size. However, poor mydriasis were found in many eyes despite maximum instillation was used. From the clinical observation, we found the packing of mydriatic drugs in lower conjunctival fornix was much more effective to dilate the pupil than instillation in some patients. The purpose of this study was to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.
- Conditions
- Preterm Infants
- Being tested
- 1% tropicamide and 2.5% phenylephrine
- Keywords
- preterm infants, mydriasis, pupil dilation
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% tropicamide and 2.5% phenylephrineDrug
For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lower conjunctival fornix packing arm. For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. Receives: Drug: 1% tropicamide and 2.5% phenylephrine |
| 2 | Active comparator | Conventional instillation arm. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each. Receives: Drug: 1% tropicamide and 2.5% phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters
Measured: 40 minutes after mydriatric drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosanan Yospaiboon, Khon Kaen University
- Investigators
- Yosanan Yospaiboon, M.D., Principal investigator, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877175
- Sponsor's protocol ID
- I50221
- Other IDs
- HE480729
- Status last verified
- Mar 2012
- First submitted
- 6 Apr 2009
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thanathanee O, Ratanapakorn T, Morley MG, Yospaiboon Y. Lower conjunctival fornix packing for mydriasis in premature infants: a randomized trial. Clin Ophthalmol. 2012;6:253-6. doi: 10.2147/OPTH.S28714. Epub 2012 Feb 15.
PubMed 22368443
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants
- ClinicalTrials.gov ID
- NCT00877175
- Acronym / sponsor ID
- I50221
- Conditions
- Preterm Infants
- Keywords
- preterm infants, mydriasis, pupil dilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Apr 2009 (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 mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.
Detailed description
Adequate pupil dilatation was needed for screening and treatment of retinopathy of prematurity (ROP) in premature infants.In general clinical practice, mydriatic drugs were instilled many times until the pupil reached the maximum size. However, poor mydriasis were found in many eyes despite maximum instillation was used. From the clinical observation, we found the packing of mydriatic drugs in lower conjunctival fornix was much more effective to dilate the pupil than instillation in some patients. The purpose of this study was to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 1% tropicamide and 2.5% phenylephrineLower conjunctival fornix packing arm. For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. |
| 2 | Active comparator | Drug: 1% tropicamide and 2.5% phenylephrineConventional instillation arm. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each. |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams
- stable clinical course
Key exclusion criteria (3 listed)
- history of intraocular surgery or laser treatment
- previous eyedrop instillation that might affect the pupil size
- severe underlying disease or unstable clinical course that mydriatic drugs or the examination could aggravate their conditions
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% tropicamide and 2.5% phenylephrineFor the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each. | Drug | 1, 2 |
Primary outcome
The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters
Time frame: 40 minutes after mydriatric drugs
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 9 Mar 2012.
- Results publication: PubMed 22368443Thanathanee O, Ratanapakorn T, Morley MG, Yospaiboon Y. Lower conjunctival fornix packing for mydriasis in premature infants: a randomized trial. Clin Ophthalmol. 2012;6:253-6. doi: 10.2147/OPTH.S28714. Epub 2012 Feb 15.
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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.
Yosanan Yospaiboon, M.D. principal investigator
Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% tropicamide and 2.5% phenylephrine in people with Preterm Infants, run by Khon Kaen University at 1 site in Thailand.
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: finished, as of the sponsor's last update on 9 Mar 2012. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters (time frame: 40 minutes after mydriatric drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877175, which also lists 1 linked publication.
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 Mar 2012.