An interventional study of eye covers in Light Sensitivity, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Supportive care
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.
Pain management for Retinopathy of prematurity (ROP) screening focuses on pharmacological and non-pharmacological interventions during the actual eye examination. Management of pain related to increased light sensitivity during the post-mydriasis period has not been described.
This prospective, randomized study evaluated the impact of protecting the eyes from ambient light exposure post mydriasis. Vital signs and pain scales were recorded in infants randomized to either wear or not wear eye patches after mydriasis for their ROP exam. Infants less than 30 weeks gestational age or less than 1500 grams at birth were included. Standard statistical methods were used to compare vital signs and pain scores for each group at baseline, 1 and 3 hours after mydriasis.
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Exclusion Criteria:
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
Behavioral: eye covers
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
Also known as: eye patches (Natus biliband)
Heart Rate
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
Time frame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
Respiratory Rate
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
Time frame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
Oxygen Percent Saturation
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
Time frame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
Pain
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores \> to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.
Time frame: pre-mydriasis, 1 hour and 3 hours after mydriatic drops
July 2011 to september 2012. At the University of Texas medical Branch.
| Milestone | Eye Patch Initially Then no Eye Patch | no Eye Patches Initially Then Eye Patches |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 13 |
| Not completed | 0 | 1 |
| Withdrew: Needed treatment for rop | 0 | 1 |
| Milestone | Eye Patch Initially Then no Eye Patch | no Eye Patches Initially Then Eye Patches |
|---|---|---|
| Started | 14 | 13 |
| Completed | 13 | 13 |
| Not completed | 1 | 0 |
| Withdrew: Discharged prior to rop #2 | 1 | 0 |
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
| Beats per minutes | Eye Patches Covers (ROP #1 and ROP #2) | no Eye Patches Covers (ROP #1 and ROP #2) |
|---|---|---|
| Baseline | 154 ± 8 | 154 ± 12 |
| 1 hour post dilation | 152 ± 8 | 163 ± 10 |
| 3 hour post dilation | 154 ± 8 | 164 ± 9 |
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
| Breaths per minutes | Eye Patches Covers | no Eye Patches Covers |
|---|---|---|
| Baseline | 54 ± 13 | 47 ± 8 |
| 1 hour post dilation | 54 ± 13 | 52 ± 13 |
| 3 hour post dilation | 55 ± 11 | 50 ± 10 |
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
| percent saturation | Eye Patches Covers | no Eye Patches Covers |
|---|---|---|
| Baseline | 98 ± 3 | 98 ± 3 |
| 1 hour post dilation | 98 ± 3 | 98 ± 3 |
| 3 hour post dilation | 98 ± 3 | 98 ± 2 |
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores \> to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.
| units on a scale | Eye Patches Covers | no Eye Patches Covers |
|---|---|---|
| Baseline | 0.4 ± 0.3 | 0.3 ± 0.5 |
| 1 hour post dilation | 0.1 ± 0.2 | 1.1 ± 0.7 |
| 3 hour post dilation | 0.2 ± 0.2 | 1 ± 0.6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eye Patches Covers | — | 0/14 (0%) | 0/14 (0%) |
| no Eye Patches Covers | — | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Eye Patches Initially Then no Patches | no Eye Patches Initially Then Eye Patches | Total |
|---|---|---|---|
| <=18 years | 14 | 14 | 28 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Eye Patches Initially Then no Patches | no Eye Patches Initially Then Eye Patches | Total |
|---|---|---|---|
| Mean | 0.54 ± 0.04 | 0.53 ± 0.04 | 0.53 ± 0.04 |
| Sex: Female, Male(Participants) | Eye Patches Initially Then no Patches | no Eye Patches Initially Then Eye Patches | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 8 | 7 | 15 |
| Region of Enrollment(participants) | Eye Patches Initially Then no Patches | no Eye Patches Initially Then Eye Patches | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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The University of Texas Medical Branch, Galveston →