ROP Screening: Comparison of Pain Using Two Eyelid Retractors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-20

Study Completion Date

2024-06-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain During ROP Exam

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Spring loaded retractor

The Alfonso Eyelid Speculum, newborn size

ROP exam with spring loaded retractor

Intervention Type PROCEDURE

Screw retractor

Cook Eyelid Speculum, infant size

ROP exam with screw retractor

Intervention Type PROCEDURE

Interventions

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ROP exam with spring loaded retractor

Intervention Type PROCEDURE

ROP exam with screw retractor

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

23 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No