Abstract
Purpose:
To provide hyperopic, presbyopic patients with improved near, intermediate, and distance vision using bilateral hydrogel corneal inlays.
Methods:
Twenty-two hyperopic (mean pre-op spherical equivalent (MRSE): 0.99 D (non-dominant eye) and 0.97 D (dominant eye) [+0.25 to +1.75 D]), presbyopic (mean pre-op reading add requirement: 1.89 D (both eyes) [+1.50 to +2.25 D]) subjects were implanted with 2.0 mm diameter hydrogel corneal inlays (ReVision Optics, Inc.)* under a femtosecond corneal flap, in the non-dominant eye, followed for 3 to 6 months, and then implanted with a like inlay in the dominant eye. The Optec® 6500 Vision Tester was used to record visual acuities. Ability to perform everyday tasks (five tasks for each of three distance ranges) without additional visual aid was ascertained using a questionnaire. The study was performed in conformance with an IRB-approved protocol.
Results:
The non-dominant (NONDOM) and dominant (DOM) eyes in the same subject responded similarly to the corneal inlay. In both eyes measured separately, uncorrected visual acuity (UCVA) had improved significantly at 3 months, by an average of 5 lines of near, 3 lines of intermediate, and 1 line of distance vision. Near and intermediate vision improved in 100% of the eyes. 86% of implanted NONDOM eyes and 95% of DOM eyes achieved 20/25 or better near UCVA compared to 0% preoperatively. 77% of implanted NONDOM eyes and 86% of DOM eyes achieved 20/25 or better intermediate UCVA compared to 0% preoperatively. Both groups had an average improvement of 1 line distance UCVA though two subjects lost one line of distance vision in the NONDOM eye. The average distance UCVA for each eye was 20/21. At 3 months after the second inlay, binocularly, 95% of subjects achieved 20/25 or better near UCVA and intermediate UCVA, and 100% of subjects achieved 20/20 or better distance UCVA. There was a significant improvement in task performance and patient satisfaction with bilateral inlays in comparison to pre-op. At 3 months after the 2nd implantation, 95% of subjects were satisfied or very satisfied with their overall vision.
Conclusions:
Bilateral implantation of the ReVision Optics corneal inlay is potentially an effective tool to improve near, intermediate, and distance vision in hyperopic presbyopes up to +1.75 D MRSE. *CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
Keywords: 479 cornea: clinical science •
678 refractive surgery •
653 presbyopia