An observational study in Bradycardia and Strabismus, sponsored by Alaska Blind Child Discovery. Recruiting at 1 site in United States. Open to participants aged 1 Month to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Alaska Blind Child Discovery · Observational
Observation study monitoring vital signs and anesthetic variables particularly heart rate during prospective, ocular manipulation and specifically uniform tension on extra ocular muscles during strabismus surgery.
*IRB approval from 1992 covered in letter from then IRB chair Dr. Judith Whitcomb, Anchorage, Alaska (letter 10/2020).*
Patients with ocular manipulation including those scheduled for strabismus surgery will have peri-operative variables monitored before, during and after uniform traction on extra ocular muscles (EOM). The oculocardiac reflex (OCR) will be elicited by quantified (200 gram, 10-second, square-wave) traction on Jameson muscle hook under insertion of an extra ocular muscle (EOM, rectus). Stable pre-tension heart rate, and greatest change heart rate will be recorded. Additional variables to be recorded: birthdate, gender, race, weight, iris color, pre-operative neurodevelopmental conditions, pre-operative medications, induction medications, expired carbon dioxide (CO2) levels, exhaled gas concentrations, anticholinergic medications, opioids, muscle relaxants, type of airway and the number of EOM operated.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Alaska Blind Child Discovery is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults and children undergoing ocular manipulation and tension on extra ocular muscles and strabismus surgery
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.
Exclusion Criteria:
Patients who receive anticholinergic medication before strabismus surgery
Diagnostic Test: electrocardiograph
Patients who do not received anticholinergic medication before strabismus surgery
Diagnostic Test: electrocardiograph
electrocardiograph monitor during strabismus surgery
Also known as: ECG, EKG
Percent heart rate resulting from oculocardiac reflex
Continuous variable of percent change in heart rate from stable pre-heart rate to greatest change heart rate during strabismus surgery
Time frame: 30 seconds
Anesthetic interventions
Impact of existing and emerging anesthetics on oculocardiac reflex. This shall include various existing and emerging medications and inhalation agents, dosage, routes, airway types, general anesthesia and awake, and monitor methods.
Time frame: 2 hours
Patient Characteristics
The impact of various patient characteristics on oculocardiac reflex including patient age, weight, gender and race, the presence of neuro-developmental condition.
Time frame: 2 hours
Surgeon Interventions
The impact of various aspects/phases of ocular manipulation and/or surgical technique. This includes monitored electrocardiograph during insertion of lid speculum, pressure on the globe, grasping of conjunctiva, incision of conjunctiva, dissection of Tenon's capsule, traction on extra ocular muscle, suturing extra ocular muscle, disinsertion of extra ocular muscle, re-suturing of extra ocular muscle and closure of conjunctiva.
Time frame: 2 hours
Plan to share: Yes — de-identified data on Study website
Time frame: ongoing
Access criteria: Web download
Data sharing details ↗ · www.abcd-vision.org
Started Sep 1992 (actual). Primary completion is estimated for Dec 2035, 519 months after the start.
Of 73 observational studies under Bradycardia, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 96. This study's planned 519 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alaska Blind Child Discovery