• Holmes, Jonathan M (PI)

Project: Research project

Project Details


Traumatic sixth nerve palsy affects at least 6000 individuals each
year in the US. Nearly all patients initially have disabling double
vision and only about 35% and patients ultimately recover single
vision without surgery. Injection of Botulinum toxin into the
medial rectus muscle has the potential benefits of restoring single
vision more rapidly and reducing the number of patients who need
eye muscle surgery, since it reduces medial rectus contracture
during lateral rectus recovery. There is considerable controversy
in the medical community regarding the role of Botulinum in the
management of traumatic sixth nerve palsy and other ocular
motility disorders. Although uncontrolled case series have
purported benefit for Botulinum treatment of traumatic sixth nerve
palsy, a proper controlled trial is necessary to resolve the
controversy. The knowledge to be obtained from this trial will
extend beyond the management of traumatic sixth nerve palsy.
This would be the first large scale controlled trial of botulinum
use in strabismus. The trial~s findings in regard to safety and
efficacy will have broader application to other types of strabismus.

Considerable planning is still needed in order to develop a final
protocol and Manual of Procedures for a multi-center clinical trial.
In particular, the available data on the recovery rate from
traumatic sixth nerve palsy are insufficient to be able to accurately
estimate the expected outcome rate in a control group for a sample
size estimate. The proposed methodology for photographically
assessing outcome is untested and requires validation and
reliability testing before determining whether it is suitable for a
multi-center trial. It is also important for clinical centers to
prospectively collect data to document recruitment potential prior
to initiating a large-scale multi-center randomized trial.

Therefore in this Planning Grant application we propose to;
conduct a survey of pediatric ophthalmologists and neuro-
ophthalmologists as to their current management of traumatic sixth
nerve palsy for use in estimating the required sample size for a
randomized trial, recruit clinical centers and collect prospective
recruitment potential data, perform pilot testing of photographic
techniques to asses outcome, develop and test data collection
forms, develop quality of life questionnaire, develop data
coordinating center procedures, finalize the protocol and prepare a
detailed Manual of Procedures for the proposed trial.
Effective start/end date7/3/976/30/02


  • Medicine(all)