StrabismusOCRpropNCT03672435
Strabismus Recovery With Proparacaine and Oculocardiac Reflex
An observational study of Strabismus and Bradycardia, run by Alaska Blind Child Discovery.
Trial summary
Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery. Read more about this study
- Who is it for?
- Ages 3 months to 90 years
- Conditions the study is for
- Strabismus, Bradycardia, Nausea
- What is being tested?
- Topical Solution
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2010to 21 Nov 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: strabismus surgery patients
Who may be able to join
- Strabismus surgery
Who cannot join
- none
About this study
Official title: Does Proparacaine Enhance Strabismus Recovery
Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.
Read the detailed description
In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age, type of surgery. Several post-operative recovery outcome variables were prospectively monitored.
- Conditions
- Strabismus, Bradycardia, Nausea, Pain
- Being tested
- Topical Solution
- Keywords
- post operative recovery, oculocardiac reflex, extra ocular muscle, conjunctiva, numbing drop, heart rate
- Medical subject headings
- Strabismus, Bradycardia, Nausea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical SolutionDrug
Also called proparacaine
proparacaine 0.5% eye drop
| Study group | Role | What they receive |
|---|---|---|
| proparacaine | Received topical proparacaine 0.5% with routine antibiotic-steroid ointment in operative eye(s) following strabismus surgery Receives: Drug: Topical Solution | |
| No proparacaine | Received no topical proparacaine 0.5% but did receive routine antibiotic-steroid ointment in the operative eye(s) following strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain (post op pain Likert scale)
pain scale description / observation.. Pain is ranked by patient or nurse from 0 (no pain) to 9 (much pain)
Measured: hours (1-4) in recovery room
Secondary outcomes (3)
nausea
observed or described nausea (presence or absence of nausea / vomiting)
Measured: hours (1-4) in recovery room
heart rate
recovery room heart rate
Measured: hours (1-4) while in recovery room
time to recovery
time in recovery room
Measured: minutes (30-240) from entry recovery room to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start29 Jul 2010
- Primary completion21 Nov 2013
- Study completion21 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Alaska Blind Child Discovery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W Arnold, MD, Principal investigator, Alaska Blind Child Discovery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672435
- Sponsor's protocol ID
- ABCD OCR proparacaine
- Acronym
- OCRprop
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Website access
Publications
Arnold RW, Bond AN. Does Topical Proparacaine Improve Postoperative Comfort After Strabismus Surgery? Clin Ophthalmol. 2019 Nov 20;13:2279-2283. doi: 10.2147/OPTH.S230498. eCollection 2019.
PubMed 31819352Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5.
PubMed 29733898
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Proparacaine Enhance Strabismus Recovery
- ClinicalTrials.gov ID
- NCT03672435
- Acronym / sponsor ID
- OCRprop / ABCD OCR proparacaine
- Conditions
- Strabismus, Bradycardia, Nausea, Pain
- Keywords
- post operative recovery, oculocardiac reflex, extra ocular muscle, conjunctiva, numbing drop, heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Alaska Blind Child DiscoveryUniversity, hospital or other
- Study start
- 29 Jul 2010 (actual)
- Primary completion
- 21 Nov 2013 (actual)
- Study completion
- 21 Nov 2013 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.
Detailed description
In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age, type of surgery. Several post-operative recovery outcome variables were prospectively monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proparacaine | – | Drug: Topical SolutionReceived topical proparacaine 0.5% with routine antibiotic-steroid ointment in operative eye(s) following strabismus surgery |
| No proparacaine | – | –Received no topical proparacaine 0.5% but did receive routine antibiotic-steroid ointment in the operative eye(s) following strabismus surgery |
Who may qualify
- Ages
- 3 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- strabismus surgery patients
Key inclusion criteria (1 listed)
- Strabismus surgery
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical SolutionAlso: proparacaineproparacaine 0.5% eye drop | Drug | proparacaine |
Primary outcome
pain (post op pain Likert scale)
Time frame: hours (1-4) in recovery room
pain scale description / observation.. Pain is ranked by patient or nurse from 0 (no pain) to 9 (much pain)
3 secondary outcomes
nausea
Time frame: hours (1-4) in recovery room
heart rate
Time frame: hours (1-4) while in recovery room
time to recovery
Time frame: minutes (30-240) from entry recovery room to discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 31819352Arnold RW, Bond AN. Does Topical Proparacaine Improve Postoperative Comfort After Strabismus Surgery? Clin Ophthalmol. 2019 Nov 20;13:2279-2283. doi: 10.2147/OPTH.S230498. eCollection 2019.
- Results publication: PubMed 29733898Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5.
- Individual participant dataSharing planned: Yes. Study Website access
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Arnold, MD principal investigator
Alaska Blind Child Discovery
Questions about this trial
What is this clinical trial studying?
An observational study of Strabismus and Bradycardia, run by Alaska Blind Child Discovery.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (post op pain Likert scale) (time frame: hours (1-4) in recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.