ROP Screening: Comparison of Pain Using Two Eyelid Retractors

August 9, 2023 updated by: Debra Skopec, Advocate Health Care

Retinopathy of Prematurity Screening: Comparison of Pain Using Two Eyelid Retractors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Children's Hospital-Oak Lawn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 8 months (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Preterm infants, who need an ROP exam based on clinical indication.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes
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.
5 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bradycardia
Time Frame: 5 minutes
Episodes of bradycardia will be recorded during the eye exam
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advocate Health Care

Investigators

  • Principal Investigator: Debra L Skopec, RN, BSN, Advocate Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimated)

June 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • K5900211
  • 5823 (Advocate IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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