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 date||7/3/97 → 6/30/02|
- National Institutes of Health: $77,293.00