Light Sensitivity
Conditions
Keywords
pain, mydriasis, light
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALeye 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 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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | pre-mydriasis, 1 hour and 3 hours after mydriatic drops | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate | pre-mydriasis, 1 hour and 3 hours after mydriatic drops | 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 |
| Oxygen Percent Saturation | pre-mydriasis, 1 hour and 3 hours after mydriatic drops | 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 |
| Pain | pre-mydriasis, 1 hour and 3 hours after mydriatic drops | 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. |
Countries
United States
Participant flow
Recruitment details
July 2011 to september 2012. At the University of Texas medical Branch.
Pre-assignment details
60 neonates were excluded prior to randomization since they did not meet inclusion criteria, refused to participate or other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Eye Patches Initially Then no Patches 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. 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. | 14 |
| no Eye Patches Initially Then Eye Patches The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. 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. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| ROP #1 | Needed treatment for ROP | 0 | 1 |
| ROP #2 | discharged prior to ROP #2 | 1 | 0 |
Baseline characteristics
| Characteristic | no Eye Patches Initially Then Eye Patches | Eye Patches Initially Then no Patches | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 0.53 years STANDARD_DEVIATION 0.04 | 0.54 years STANDARD_DEVIATION 0.04 | 0.53 years STANDARD_DEVIATION 0.04 |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eye Patches Covers (ROP #1 and ROP #2) | Heart Rate | Baseline | 154 Beats per minutes | Standard Deviation 8 |
| Eye Patches Covers (ROP #1 and ROP #2) | Heart Rate | 1 hour post dilation | 152 Beats per minutes | Standard Deviation 8 |
| Eye Patches Covers (ROP #1 and ROP #2) | Heart Rate | 3 hour post dilation | 154 Beats per minutes | Standard Deviation 8 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Heart Rate | Baseline | 154 Beats per minutes | Standard Deviation 12 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Heart Rate | 1 hour post dilation | 163 Beats per minutes | Standard Deviation 10 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Heart Rate | 3 hour post dilation | 164 Beats per minutes | Standard Deviation 9 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eye Patches Covers (ROP #1 and ROP #2) | Oxygen Percent Saturation | Baseline | 98 percent saturation | Standard Deviation 3 |
| Eye Patches Covers (ROP #1 and ROP #2) | Oxygen Percent Saturation | 1 hour post dilation | 98 percent saturation | Standard Deviation 3 |
| Eye Patches Covers (ROP #1 and ROP #2) | Oxygen Percent Saturation | 3 hour post dilation | 98 percent saturation | Standard Deviation 3 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Oxygen Percent Saturation | Baseline | 98 percent saturation | Standard Deviation 3 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Oxygen Percent Saturation | 1 hour post dilation | 98 percent saturation | Standard Deviation 3 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Oxygen Percent Saturation | 3 hour post dilation | 98 percent saturation | Standard Deviation 2 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eye Patches Covers (ROP #1 and ROP #2) | Pain | Baseline | 0.4 units on a scale | Standard Deviation 0.3 |
| Eye Patches Covers (ROP #1 and ROP #2) | Pain | 1 hour post dilation | 0.1 units on a scale | Standard Deviation 0.2 |
| Eye Patches Covers (ROP #1 and ROP #2) | Pain | 3 hour post dilation | 0.2 units on a scale | Standard Deviation 0.2 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Pain | 3 hour post dilation | 1 units on a scale | Standard Deviation 0.6 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Pain | Baseline | 0.3 units on a scale | Standard Deviation 0.5 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Pain | 1 hour post dilation | 1.1 units on a scale | Standard Deviation 0.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eye Patches Covers (ROP #1 and ROP #2) | Respiratory Rate | Baseline | 54 Breaths per minutes | Standard Deviation 13 |
| Eye Patches Covers (ROP #1 and ROP #2) | Respiratory Rate | 1 hour post dilation | 54 Breaths per minutes | Standard Deviation 13 |
| Eye Patches Covers (ROP #1 and ROP #2) | Respiratory Rate | 3 hour post dilation | 55 Breaths per minutes | Standard Deviation 11 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Respiratory Rate | Baseline | 47 Breaths per minutes | Standard Deviation 8 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Respiratory Rate | 1 hour post dilation | 52 Breaths per minutes | Standard Deviation 13 |
| no Eye Patches Covers (ROP #1 and ROP #2) | Respiratory Rate | 3 hour post dilation | 50 Breaths per minutes | Standard Deviation 10 |