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NCT03349515 · ClinicalTrials.gov registry record · Phase 4

The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.

A Phase 4 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 4
Development phase
106
Enrollment target

NCT03349515: Completed Phase 4 study, sponsored by Medical University of South Carolina.

NCT03349515 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 106 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03349515, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 4
Development phase
106 participants
Enrollment target

Study Summary

Determine whether the application of povidone-iodine ophthalmic solution onto the ocular surface causes a change in respiration in children undergoing strabismus surgery with general anesthesia. Hypothesis: The application of povidone-iodine ophthalmic solution to the ocular surface causes a change in respiration in children during general anesthesia prior to strabismus surgery.

Primary Outcome

The iPhone stopwatch application will be used and its 'lap button' feature to collect the respiration peak intervals (in seconds) for 5 breaths. Specifically, at the patient's peak inspiration (as seen on the capnography), the study member will start the stopwatch and proceed to hit the 'lap' button for the next 5 consecutive inspiration peaks. These data intervals will be recorded on the data sheet after the 5 breaths are over, as the intervals are conveniently stored and numbered below the sto

Interventions

  • DRUG Provodine-Iodine Solution
  • DRUG Group B will receive three drops in each eye of ophthalmic balanced salt solution.

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2017-11-02
Est. Completion 2018-09-19
Phase Phase 4

What the finished NCT03349515 record still lists

NCT03349515 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 2 interventions - of which Provodine-Iodine Solution is the first listed.

NCT03349515 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03349515 about?

NCT03349515 is a clinical study titled "The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia.". Determine whether the application of povidone-iodine ophthalmic solution onto the ocular surface causes a change in respiration in children undergoing strabismus surgery with general anesthesia. Hypothesis: The application of povidone-iodine ophthalmic solution to the ocular surface causes a change...

What is the current status of trial NCT03349515?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 106 participants. The study started on 2017-11-02. Estimated completion is 2018-09-19.

What interventions are being tested in trial NCT03349515?

The interventions under investigation include: Provodine-Iodine Solution (DRUG), Group B will receive three drops in each eye of ophthalmic balanced salt solution. (DRUG).

Who is sponsoring clinical trial NCT03349515?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03349515's enrollment target sits among peer trials

106 747th of 2000 higher than 1,252 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT03349515, the US trial registry maintained by the National Library of Medicine. NCT03349515 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.