Purpose: This report is a summary of the data of the IOLAB, Inc pediatric i
ntraocular lens (IOL) implantation investigation. The goal of this study wa
s 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 recei
ved 171 styles of IOLs implanted by 361 US investigators. Preoperative, ope
rative, and postoperative status reports over the first year were required
for each eye entered into the study. Annual visit reports were requested th
ereafter to determine the long-term effects. The study was terminated in No
vember 1995. All IOLs were obtained from IOLAB, Inc (now Chiron Vision Corp
). Results: Reporting compliance was 98.3% for the preoperative and operati
ve reports, 45.1% at 1 year, and 13.8% at 3 years; The subjects' ages range
d from younger than 1 year to 17 years. Nine subjects (0.7%) were younger t
han 1 year, with the largest group of 533 subjects (42.3%) aged between 6 a
nd 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 ant
erior chamber (4.1%), iridocapsular (0.71%), posterior chamber (93.6%), and
unrecorded (1.59%). There were 130 adverse reactions that required seconda
ry 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 o
n 563 eyes at 1 year after surgery. Overall, 52.8% of all eyes attained a v
isual acuity of 20/40 or better by the 1-year visit, and only 15.5% had vis
ual acuity worse than 20/200. In general, the older patient, traumatic cata
ract, 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 th
e safety and efficacy of IOL implantation in children. The study results ar
e compromised by the almost 50% loss of follow-up at the 1-year evaluation.
Other variables that most likely influenced outcome results were the metho
ds of cataract extraction, medical management, and IOL design, all of which
evolved dramatically over the time course of the study. Despite these issu
es, 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 rem
aining 45.1% of eyes in the study.