OBJECTIVE To assess the safety and efficacy of Intacs inserts for the treatment of mild to moderate keratoconus. METHODS In a nonrandomized prospective clinical trial, 50 eyes of 37 patients with mild to moderate keratoconus were implanted with asymmetrical pairs of Intacs segments. Patients were interviewed and observed preoperatively and 24 hours, 1 week, 1, 3, 6, and 12 months postoperatively. Main outcome measures were uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, satisfaction with vision and trouble with vision, Visual Function-7 score, and surgically induced change in corneal astigmatism. RESULTS Of the 50 operations performed, 92% were successful. Mean follow-up was 6.3 +/- 3.2 months. In 4 (8%) eyes, both Intacs segments were removed. In addition, 7 refractive adjustments in 7 eyes were performed successfully to improve visual and surgical outcome. Both BSCVA and UCVA improved throughout follow-up. Visual functioning index improved from 61.6 +/- 21.1 to 80.8 +/- 22.5, and the percentage of satisfaction with vision improved from 24.3% to 87.5% at 12 months. Vector analysis of astigmatism correction showed that the mean change in corneal astigmatism was 2.9 +/- 2.9 D at 6 months postoperatively. By selecting patients in whom astigmatism correction was best (index of success >0.5), an analysis was performed to determine individual factors important in successful surgery. Preoperatively these 11 (22%) eyes did not differ significantly from the remaining eyes and the only significant value was low K readings in the flat axis. CONCLUSIONS Asymmetric Intacs placement improves BSCVA and UCVA and reduces astigmatism in patients with mild to moderate keratoconus. The procedure of Intacs placement is safe and effective. The change in astigmatism correction is unpredictable.