Derek T. Sprunger

Intraoperative sponge 5-flourouracil to reduce postoperative scarring in strabismus surgery

INTRODUCTIONnTo determine whether 5-fluorouracil is effective in reducing scarring after strabismus surgery we used rectus muscle surgery in experimental animals to compare a single intraoperative dose of 5-fluorouracil with mitomycin C and to compare results in similarly treated controls not receiving these antimetabolites.nnnMETHODSnMuscle resections were performed on eight rabbits (16 eyes). Four eyes had 5-fluorouracil (50 mg/ml), and four eyes received mitomycin C (0.2 mg/ml), each of which was applied during surgery on an ophthalmic sponge for 5 minutes. Eight eyes served as controls. Six weeks after surgery conjunctival vascularity, muscle length-tension curves, muscle disinsertion force, and the histologic degree of scarring were assessed.nnnRESULTSnThe mitomycin C-treated eyes clearly had more conjunctival avascularity and a lower disinsertion force. Both treated groups had flatter length-tension curves and less scarring on histologic examination than the control eyes.nnnCONCLUSIONSnAntifibroproliferative therapy with intraoperative sponge 5-fluorouracil appears as effective as, and is possibly safer than, mitomycin C. It may be a useful adjunct in recurrent strabismus surgery or in other situations where a risk of excessive postoperative scarring exists.

The IOLAB, Inc pediatric intraocular lens study

Abstract Purpose: This report is a summary of the data of the IOLAB, Inc pediatric intraocular lens (IOL) implantation investigation. The goal of this study was to evaluate the safety and efficacy of IOL implantation for the treatment of pediatric aphakia, pending approval by the Food and Drug Administration. Methods: From May 1981 to July 1994, a total of 1260 pediatric eyes received 171 styles of IOLs implanted by 361 US investigators. Preoperative, operative, and postoperative status reports over the first year were required for each eye entered into the study. Annual visit reports were requested thereafter to determine the long-term effects. The study was terminated in November 1995. All IOLs were obtained from IOLAB, Inc (now Chiron Vision Corp). Results: Reporting compliance was 98.3% for the preoperative and operative reports, 45.1% at 1 year, and 13.8% at 3 years. The subjects ages ranged from younger than 1 year to 17 years. Nine subjects (0.7%) were younger than 1 year, with the largest group of 533 subjects (42.3%) aged between 6 and 12 years at the time of surgery. Cataract types were congenital (45.6%), traumatic (37.1%), secondary (11%), senile (0.95%), and unrecorded (5.4%). The IOL was implanted primarily in 74.8% of cases and secondarily in 21.4% of cases. There was no record in 3.8% of the cases. IOL types included anterior chamber (4.1%), iridocapsular (0.71%), posterior chamber (93.6%), and unrecorded (1.59%). There were 130 adverse reactions that required secondary surgical intervention. The most frequently performed surgical procedures included lens removal without replacement, vitrectomy, lens repositioning, and lens replacement. More than half (52%) of all eyes had a visual acuity of 20/200 or worse before surgery; amblyopia was reported in 21.1% of all participants at baseline. Postoperative visual acuity data were available on 563 eyes at 1 year after surgery. Overall, 52.8% of all eyes attained a visual acuity of 20/40 or better by the 1-year visit, and only 15.5% had visual acuity worse than 20/200. In general, the older patient, traumatic cataract, and secondary cataract categories were overrepresented in the better visual acuity outcome group. Conclusion: The IOLAB, Inc pediatric IOL study is the first multiple- practitioner, national study designed to evaluate the safety and efficacy of IOL implantation in children. The study results are compromised by the almost 50% loss of follow-up at the 1-year evaluation. Other variables that most likely influenced outcome results were the methods of cataract extraction, medical management, and IOL design, all of which evolved dramatically over the time course of the study. Despite these issues, pediatric IOL implantation seems to be a reasonable treatment modality for aphakia, on the basis of the available 1-year follow-up data of the remaining 45.1% of eyes in the study. (J AAPOS 1999;3:295-302)