Objective: To evaluate the use of INTACS micro-thin prescription inserts (K
era Vision, Inc., Fremont, CA) for the treatment of keratoconus.
Design: Prospective, nonrandomized (self-control led) comparative trial.
Participants/Intervention: Ten patients from our prospective clinical study
who had completed 12 months of follow-up were evaluated. All patients had
keratoconus with clear central corneas and were contact lens intolerant. Af
ter reviewing corneal pachymetry and topography of individual patients, INT
ACS inserts of 0.45-mm thickness were placed in the inferior cornea to lift
the cone and INTACS of 0.25-mm thickness were inserted superiorly to count
erbalance and flatten the overall anterior corneal surface.
Main Outcome Measures: Differences between preoperative and postoperative u
ncorrected visual acuity, best spectacle-corrected visual acuity, manifest
refraction, and keratometry values were statistically assessed. Changes in
corneal ectasia were evaluated by reviewing cornectopographic maps.
Results: No intraoperative complications occurred in this series of patient
s. Spherical equivalent error and refractive astigmatism were reduced with
INTACS inserts treatment. Postoperative month 12 uncorrected visual acuity
(logarithm of the minimum angle of resolution [logMAR] mean, 0.35, standard
deviation [SD], 0.16 [similar to 20/50, similar to2 lines]) was significan
tly better than preoperative (logMAR mean, 1.05; SD, 0.33 [similar to 20/20
0, similar to3 lines]; P less than or equal to0.05). Average best spectacle
-corrected visual acuity at postoperative month 12 was improved by approxim
ately two lines compared with baseline (logMAR mean, 0.22; SD, 0.12 [simila
r to 20/32, similar to1 line]; logMAR mean, 0.38; SD, 0.13 [similar to 20/5
0, similar to1 line], respectively). Topographic corneal shape (size and he
ight of the cone) was improved for all subjects after insert placement.
Conclusions: INTACS micro-thin prescription inserts seem to provide a viabl
e method for treating clear corneal keratoconus for patients who are contac
t lens intolerant. The corneal steepening and astigmatism associated with k
eratoconus were reduced, and visual acuity was improved with treatment in a
lmost all eyes. Ophthalmology 2001;108:1409-1414 (C) 2001 by the American A
cademy of Ophthalmology.