ROP Screening: Comparison of Pain Using Two Eyelid Retractors
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/26/2019 |
| Start Date: | June 2014 |
| End Date: | December 2020 |
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.
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.
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.
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.
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
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