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ROP Screening: Comparison of Pain Using Two Eyelid Retractors

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ClinicalTrials.gov Identifier: NCT02152046
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2014
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Debra Skopec, Advocate Health Care

Brief Summary:

Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.

Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam.

The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.

The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.


Condition or disease Intervention/treatment
Pain During ROP Exam Procedure: ROP exam with spring loaded retractor Procedure: ROP exam with screw retractor

Detailed Description:

Retinopathy of prematurity (ROP) is a major cause of blindness in the world. It is a vasoproliferative retinopathy that affects premature and low birth-weight infants. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.

Only two studies alluded to the impact of the eyelid speculum on the pain response and score. Specifically, Hered and Gyland, questioned whether the Alfonso, spring loaded, eyelid lid speculum due to its forceful opening of the eyelid causes more pain. However, no studies were found that included the type of eyelid speculum as a variable of study. In addition, no studies have compared the effect of different eyelid speculums on the pain response.

Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam. The investigators team recognizes that the insertion of the eyelid speculum causes a pain response in these infants and would like to determine if there is a difference in the level of that response between the two speculums.

The investigators study will test the difference in pain response when using either a spring loaded eyelid speculum or screw loaded speculum during an ROP exam on premature infants.

The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.

The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Retinopathy of Prematurity Screening: Comparison of Pain Using Two Eyelid Retractors
Study Start Date : June 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Spring loaded retractor
The Alfonso Eyelid Speculum, newborn size
Procedure: ROP exam with spring loaded retractor
Screw retractor
Cook Eyelid Speculum, infant size
Procedure: ROP exam with screw retractor



Primary Outcome Measures :
  1. N-PASS Score immediately after the second eye [ Time Frame: 5 minutes ]
    With each exam, an N-PASS score will be recorded: just prior to the start of the exam; between each eye; at the end of the exam and every minute for five minutes from the completion of the exam.


Secondary Outcome Measures :
  1. time it takes for neonates pain score to return to baseline or up to 5 minutes after the end of the exam [ Time Frame: 5 minutes ]
    Time in seconds will be recorded via stopwatch for the entire eye exam, starting with the insertion of the eyelid speculum in the right eye and concluding when the eyelid speculum is removed from the left eyelid.

  2. Maximum pain score recorded [ Time Frame: 5 minutes ]
    With each exam, an N-PASS score will be recorded: just prior to the start of the exam; between each eye; at the end of the exam and every minute for five minutes from the completion of the exam.


Other Outcome Measures:
  1. Bradycardia [ Time Frame: 5 minutes ]
    Episodes of bradycardia will be recorded during the eye exam



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Preterm infants, who need an ROP exam based on clinical indication.
Criteria

Inclusion Criteria:

  • Neonates who are born at less than or equal to 32 weeks gestation or are less than or equal to 1500 grams birth weight

Exclusion Criteria:

  • Neonates who are paralyzed or have a negative pain score
  • Neonates undergoing an Avastin injection
  • Neonates undergoing a Retcam exam
  • Neonates transferred to another unit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152046


Locations
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United States, Illinois
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Sponsors and Collaborators
Advocate Health Care
Investigators
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Principal Investigator: Debra L Skopec, RN, BSN Advocate Health Care

Publications:
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Responsible Party: Debra Skopec, RN, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02152046     History of Changes
Other Study ID Numbers: K5900211
5823 ( Other Identifier: Advocate IRB )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Retinopathy of Prematurity
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases