The broad objective of this research proposal is to decrease the morbidity of glaucoma filtration surgery. This objective will be accomplished by achieving the specific aims of estimating the incidence of the major complications of endophthalmitis, suprachoroidal hemorrhage, and central vision loss from other causes, and determining the risk factors for these complications. Data will be collected prospectively for 3 years from over 300 ophthalmologists performing a total of 20,000 operations a year. This will allow us to collect enough data to make statistically valid conclusions about the incidence of these complications. We will be able to collect this large amount of data from so many sites because of a novel method of data acquisition. The participating surgeons will only submit a minimal amount of information for each patient and the information will be transmitted by FAX directly into a computerized database. The study coordinator will assiduously monitor the data collection and track down missing and incomplete data. In a second phase of the study, the medical records of the eyes with surgical complications will be reviewed along with four matched controls for each case. Information will be abstracted from each chart concerning race, age, gender, use of antifibrosis agents, refractive error, lens status, type of surgery, additional surgery or procedures, post-operative ocular medications, presence of bleb leak or blepharitis, and systemic diseases. From this information we will determine the risk factors for the complications of surgery. The results of the study may allow physicians to reduce the morbidity of glaucoma surgery by altering their indications for surgery, surgical technique, and postoperative follow-up. If successful, this study design could serve as a model for future large-scale, cost-effective, observational studies. |
