International Multi-Center Clinical Trial for Correcting Emmetropic Presbyopia With Corneal Inlay: 36-Month Results
Narrative Responses:
Purpose
To evaluate the effectiveness and long-term visual performance of patients implanted with small aperture intracorneal inlay (KAMRA, AcuFocus, Inc.) for the treatment of presbyopia in emmetropes.
Methods
Multi-center, prospective, non-randomized clinical trial in 507 emmetropic presbyopes. Patients were between 45-60 years of age, spherical equivalent refraction of +0.50D to -0.75D, best-correct visual acuity of 20/20 and uncorrected near visual acuity of 20/40 to 20/100. The inlay was implanted monocularly in the non-dominant eye into either a pocket or under a flap. Patients were followed for 36-months.
Results
At 36 months, the mean uncorrected distance, intermediate and near acuities in the inlay implanted eye were 20/20, 20/25 and J2 respectively. There were 3.4 lines of improvement in the mean uncorrected near visual acuity (J8 to J2). 53% of patients showed greater than a 3-line improvement and 78% showed greater than a 2-line improvement in near acuity.
Conclusion
The KAMRA inlay improves near and intermediate vision with minimal compromise in distance acuity. Results are maintained over the long-term. Use of a small-aperture corneal inlay for treatment of presbyopia in emmetropes is an effective procedure.