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NCT01860534 · ClinicalTrials.gov registry record · NA
"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"
A NA study of Light Sensitivity, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT01860534: Completed NA study of Light Sensitivity, sponsored by The University of Texas Medical Branch, Galveston.
NCT01860534 is a NA study of Light Sensitivity that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01860534, a NA study of Light Sensitivity, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL eye covers
Study Locations (1)
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-09 |
| Phase | NA |
What the finished NCT01860534 record still lists
NCT01860534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Light Sensitivity appearing as the primary indexed condition, and to 1 intervention - of which eye covers is the first listed.
NCT01860534 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01860534 about?
NCT01860534 is a clinical study titled ""Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"". 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 ...
What is the current status of trial NCT01860534?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2011-07. Estimated completion is 2012-09.
What conditions does trial NCT01860534 study?
This clinical trial studies the following conditions: Light Sensitivity.
What interventions are being tested in trial NCT01860534?
The interventions under investigation include: eye covers (BEHAVIORAL).
Who is sponsoring clinical trial NCT01860534?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01860534 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01860534's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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