Background: The theoretical benefits of synthetic keratophakia over co
nventional corneal lamellar procedures are the elimination of donor co
ncerns and superior refractive predictability Additionally, synthetic
material can be inspected for optical quality and power, and it can be
sterilized. Furthermore, visual recovery should be more rapid since e
pithelium is not removed from the central part of the cornea and the n
eed for keratocyte repopulation is eliminated. Objective: To present r
esults on patients who received an intracorneal implant (Kerato-Gel, A
llergan Medical Optics, Irvine, Calif) that was made from lidofilcon A
, a glucose-permeable hydrogel with an equilibrium water content of 68
%. Methods: The intracorneal implants were implanted in 35 adult patie
nts for correction of aphakia. Inclusion criteria excluded patients wi
th aphakia who were candidates for intraocular lenses. Results: A tota
l of 19 patients were followed up through 2 years postoperatively. For
16 patients with 2-year postoperative refractive data, the average sp
herical equivalent was -0.63 +/- 2.07 diopters (D). At 2 years, 88% of
patients were within +/-3.00 D of plano and 50% were within +/-1.00 D
. The mean change in Snellen's line for corrected visual acuity was -3
.25 lines at 2 years for an patients and -2.0 lines for a subgroup of
five patients who were free of vision-limiting preoperative disease. C
onclusions: Results suggest that this intracorneal implant is well tol
erated by the cornea and can provide predictable refractive results in
patients with high-risk aphakia. Limitations of the procedure are une
ven microkeratome resections, loss of best-corrected visual acuity, an
d irregular astigmatism in some patients. Although these data show goo
d evidence of biocompatibility of the implant material, technical surg
ical progress is needed to advance this procedure into clinical therap
eutic practice.