Purpose: To prospectively study the effects of the use of Intacs microthin prescription inserts for the management of keratoconus.
Design: Prospective nonrandomized clinical trial.
Methods: Thirty-three eyes of 26 keratoconus patients (17 males and 9 females) ages 21 to 51 years (mean age, 32 +/- 9.7 years) were included in the current study. All patients had clear central corneas and contact lens intolerance. Patients were excluded if any of the following criteria applied after the preoperative examination: previous intraocular or corneal surgery; history of herpes keratitis; diagnosed autoimmune disease; and systemic connective tissue disease. Two Intacs segments of 0.45-mm thickness were inserted in the cornea of each eye, aiming at embracing the keratoconus area to try to achieve maximal flattening. Preoperative examination included uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), manifest refraction, keratometric data, and corneal topography.
Results: Intacs were successfully implanted in all eyes. In one eye Intacs were removed after 3 months because of their improper (superficial) placement. The follow-up ranged from 1 to 24 months (mean: 11.3 months). The mean UCVA significantly improved from 0.13 +/- 0.14 (range, counting fingers [CF]-0.5) to 0.39 +/- 0.27 (range, CF-1.0) (P <.01). Of 33 eyes, 2 eyes lost 1 line of UCVA, and 3 eyes maintained the preoperative UCVA, whereas the rest (28 eyes) experienced a 1- to 10-line gain. The mean BCVA also improved from 0.47 +/- 0.31 (range, CF-1.0) to 0.64 +/- 0.26 (range, 0.1-1.0) (P <.01). Of 33 eyes, 4 eyes experienced 1- to 2-line loss of BCVA, 4 eyes maintained the preoperative BCVA, whereas the rest (25 eyes), experienced a 1- to 6-line gain. Of 3 patients (3 eyes) with unsatisfactory results, 1 patient improved with one segment removal and in 2 patients the segments were permanently removed. One of these eyes underwent successful PKP.
Conclusions: With mean follow-up of 11.3 months, intracorneal ring segments implantation improved UCVA and BCVA in the majority of the keratoconus patients. Even though the results are encouraging, concern still exists regarding the predictability as well as the long-term effect of such an approach for the management of keratoconus.