A Phase 4 interventional study of Provodine-Iodine Solution and Group B will receive three drops in each eye of ophthalmic balanced salt solution. in Strabismus, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 1 Year to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Other
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.
The study is randomized and single blind. One hundred children were randomly assigned to have either povidone-iodine (group A) or balanced salt solution (BSS) (group B) eye drops instilled into their eyes during anesthesia just prior to strabismus surgery. After induction of anesthesia and insertion of an LMA while the patient was at a steady state of anesthesia and spontaneously breathing sevoflurane in oxygen, 3 drops of either povidone-iodine or BSS was instilled into each eye (right eye first). Respiratory rate was determined by measuring the peak-to-peak interval on the capnograph. This is similar to calculating heart rate by measuring the R-R interval on an ECG. HR, BP, SaO2, EtCO2, and expired sevoflurane were measured in each patient. Medical history information collected included history of prior surgeries, co-existing diseases, or apnea. Appropriate statistical analyses were performed for comparisons between the groups with respect to respiratory rate, HR, BP, expired sevoflurane, and co-existing diseases.
142 studies on the registry are indexed under Strabismus; 31 are open to participants now.
This study's enrollment of 106 is above the median of 60 across 82 interventional studies indexed under Strabismus.
Browse Strabismus studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children between the ages of 1 year and 17 years
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.
Drug: Provodine-Iodine Solution
Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
Drug: Group B will receive three drops in each eye of ophthalmic balanced salt solution.
Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes.
Group B will receive three drops in each eye of ophthalmic balanced salt solution. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes
Breath Duration
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 stopwatch in the app
Time frame: 5 minutes
| Milestone | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. |
|---|---|---|
| Started | 55 | 51 |
| Completed | 50 | 50 |
| Not completed | 5 | 1 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Physician decision | 3 | 1 |
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 stopwatch in the app
| seconds | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. |
|---|---|---|
| Breath 1 | 2.14 ± 0.621 | 2.18 ± 0.626 |
| Breath 2 | 2.26 ± 0.621 | 2.15 ± 0.626 |
| Breath 3 | 5.02 ± 0.621 | 2.18 ± 0.626 |
| Breath 4 | 5.65 ± 0.621 | 2.23 ± 0.626 |
| Breath 5 | 3.08 ± 0.621 | 2.22 ± 0.626 |
| Breath 6 | 7.47 ± 0.621 | 2.25 ± 0.626 |
| Breath 7 | 3.22 ± 0.621 | 2.20 ± 0.626 |
| Breath 8 | 2.49 ± 0.621 | 2.17 ± 0.626 |
| Breath 9 | 2.69 ± 0.621 | 2.21 ± 0.626 |
| Breath 10 | 2.49 ± 0.621 | 2.15 ± 0.626 |
| Breath 11 | 2.35 ± 0.621 | 2.2 ± 0.626 |
| Breath 12 | 2.15 ± 0.621 | 2.17 ± 0.626 |
| Breath 13 | 2.12 ± 0.621 | 2.16 ± 0.626 |
| Breath 14 | 2.14 ± 0.621 | 2.18 ± 0.626 |
| Breath 15 | 2.09 ± 0.621 | 2.09 ± 0.626 |
Collected over Adverse event data was collected during the participants surgery when eye drops were placed. This time frame was less than 30 minutes.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A - Povidone-iodine Ophthalmic Solution. | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Group B - Ophthalmic Balanced Salt Solution. | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. | Total |
|---|---|---|---|
| <=18 years | 50 | 50 | 100 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. | Total |
|---|---|---|---|
| Mean | 6.2 ± 3.9 | 6.4 ± 3.4 | 6.31 ± 3.61 |
| Sex: Female, Male(Participants) | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. | Total |
|---|---|---|---|
| Female | 33 | 27 | 60 |
| Male | 17 | 23 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 47 | 48 | 95 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 12 | 20 |
| White | 38 | 35 | 73 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Region of Enrollment(participants) | Group A - Povidone-iodine Ophthalmic Solution. | Group B - Ophthalmic Balanced Salt Solution. | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Sep 2018, 10 months.
Results were first posted in Sep 2019, 11 months after primary completion.
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