European clinical evaluation: use of Intacs for the treatment of keratoconus.

PURPOSE: To evaluate the safety and efficacy of Intacs inserts in keratoconic eyes to alter corneal shape and refractive power and stabilize the progression of corneal ectasia.

SETTING

Service d'Ophtalmologie, Bordeaux, France.

METHODS

In this prospective study, 57 eyes with clear central corneas that were diagnosed with keratoconus and contact lens intolerant were followed for up to 1 year. The primary objectives were to assess the safety of Intacs and the visual outcomes by measuring uncorrected visual acuity (UCVA), best corrected visual acuity, manifest refraction spherical equivalent, keratometry, intraocular pressure (IOP), pachymetry, and patient satisfaction. The stability of the refraction, keratometry, and visual acuity measurements was also assessed.

RESULTS

At the 6-month examination, 78% of patients showed improvement of 2 lines or more in UCVA (P<.001). Best corrected visual acuity of 20/40 or better improved from 53% of patients preoperatively to 74% of patients (P< or =.033). Manifest refraction spherical equivalent improved to 3.1 +/- 2.5 diopters (D) (P<.001) compared with the preoperative examination. Keratometry decreased a mean of -4.3 +/- 2.8 D from the preoperative readings (P< or =.002). These changes appeared to be stable over time. At 6 months, there were no adverse events, no clinically significant increase in IOP, and no decrease in central corneal thickness. In 7 of 57 eyes (12%), the Intacs were removed due to dissatisfaction with visual symptoms. There were no adverse effects or complications associated with the Intacs removal.

CONCLUSIONS

Intacs were safe and effective for treating keratoconus. All patients demonstrated improved objective visual outcomes; functional vision was restored in most patients. Intacs were removed without permanent sequelae.