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ROP Screening: Comparison of Pain Using Two Eyelid Retractors

NCT02152046 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2025-01-23

No results posted yet for this study

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.

Conditions

  • Pain During ROP Exam

Interventions

PROCEDURE

ROP exam with spring loaded retractor

PROCEDURE

ROP exam with screw retractor

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Debra L Skopec, RN, BSN · Wake Forest University Health Sciences

Eligibility

Min Age
23 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-20
Primary Completion
2024-06-24
Completion
2024-06-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02152046 on ClinicalTrials.gov