Safety and efficacy of a hydrogel inlay with laser in situ keratomileusis to improve vision in myopic presbyopic patients: one-year results.

PURPOSE: To study the safety and efficacy of implanting a hydrogel corneal inlay (Raindrop Near Vision Inlay) concurrently with performing laser in situ keratomileusis (LASIK) to treat myopic presbyopia and to compare the results with results of the same treatment in emmetropic and hyperopic patients.

SETTING

Two private clinics, Tijuana and Monterrey, Mexico.

DESIGN

Prospective nonrandomized clinical trial.

METHODS

Bilateral myopic LASIK was performed and a corneal inlay was concurrently implanted in the nondominant eye under a flap created using a femtosecond laser. Primary safety outcomes were the retention of corrected distance (CDVA) and near (CNVA) visual acuities. Efficacy was evaluated on the basis of uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities. A patient questionnaire was used to assess the preoperative and postoperative incidence of visual symptoms, the ability to perform common tasks with no correction, and patient satisfaction with vision.

RESULTS

Thirty eyes were enrolled. At each postoperative visit, the mean CDVA and CNVA were within one half line of preoperative measurements and no eye lost 2 or more lines of CDVA. The mean binocular UDVA, UIVA, and UNVA were better than 20/25 Snellen at all postoperative visits. By 6 months, 93% of patients had a binocular Snellen acuity of 20/25 or better across all visual ranges. According to patient questionnaires, 1 year after surgery, visual symptoms were at preoperative levels, 98% of all visual tasks could be easily performed without correction, and 90% of patients were satisfied or very satisfied with their overall vision.

CONCLUSION

A hydrogel corneal inlay with concurrent LASIK was safe and effective for treating myopic presbyopia.

FINANCIAL DISCLOSURE: Drs. Garza and Chayet are consultants to and investigators for Revision Optics, Inc.