N/A
Completed N=28
"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"
Light Sensitivity
Source: ClinicalTrials.gov NCT01860534 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Heart Rate — 154; 154; 152; 163 Beats per minutes
Summary
Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can persist for hours. Despite regular use of eye protection for mydriatic-induced light sensitivity for infants, children and adults, eye protection after mydriasis has not been addressed in neonates. This study examines the use of eye patches to protect the dilated pupil from light exposure and their impact on vital signs and pain scores. prevents tachycardia, tachypnea and discomfort in neonates after ROP screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate |
154; 154; 152; 163; 154; 164 | — |
| SECONDARY Respiratory Rate |
54; 47; 54; 52; 55; 50 | — |
| SECONDARY Oxygen Percent Saturation |
98; 98; 98; 98; 98; 98 | — |
| SECONDARY Pain |
0.4; 0.3; 0.1; 1.1; 0.2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- All infants with gestational age at birth of 30 weeks or less or with birth weight less than 1500g undergoing their first ROP exam in the Infant Special Care Unit (ISCU) at UTMB.
Exclusion Criteria
- Infants were excluded if they had any congenital malformation or syndrome; a history of eye surgery or were receiving inotropics medications.
Data sourced from ClinicalTrials.gov (NCT01860534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.