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Comparison of Instillation and Packing in Mydriasis for Premature Infants

Primary Purpose

Preterm Infants

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
1% tropicamide and 2.5% phenylephrine
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Infants focused on measuring preterm infants, mydriasis, pupil dilation

Eligibility Criteria

1 Month - 4 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams
  • stable clinical course

Exclusion Criteria:

  • 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

Sites / Locations

  • Srinagarind Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters

Secondary Outcome Measures

Full Information

First Posted
April 6, 2009
Last Updated
March 7, 2012
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT00877175
Brief Title
Comparison of Instillation and Packing in Mydriasis for Premature Infants
Official Title
Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
preterm infants, mydriasis, pupil dilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
1% tropicamide and 2.5% phenylephrine
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters
Time Frame
40 minutes after mydriatric drugs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams stable clinical course Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosanan Yospaiboon, M.D.
Organizational Affiliation
Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22368443
Citation
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.
Results Reference
result

Learn more about this trial

Comparison of Instillation and Packing in Mydriasis for Premature Infants

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