Clinical Performance of a Hydrogel Corneal Inlay in Hyperopic Presbyopes

Abstract

Purpose: : To provide hyperopic, presbyopic patients with improved near and intermediate vision using a hydrogel corneal inlay.

Methods: : Eighteen hyperopic (mean pre-op spherical equivalent (MRSE): 1.11 D [+0.50 to +1.75 D]), presbyopic (mean pre-op reading add requirement: 2.0 D [+1.50 to +2.25 D]) subjects were implanted with 2.0 mm diameter hydrogel corneal inlays (ReVision Optics, Inc.)*. 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: : At the 1 month post-op examination, the less hyperopic group of subjects (mean pre-op MRSE: 0.83 D [+0.50 to +1.00 D], N=9) were compared to the more hyperopic group of patients (mean pre-op MRSE 1.43 D [> +1.00 D], N=9) subjects. Preoperatively, the group of less hyperopic subjects had better UCVA at all distances but the differences were not statistically significant at the 95% confidence level. In all implanted eyes, near uncorrected visual acuity (UCVA) had improved at 1 month, by an average of > 5lines. 78% of implanted eyes achieved 20/25 or better near UCVA compared to 0% preoperatively. The average near UCVA for each group was 20/25. Intermediate UCVA improved in 100% of implanted eyes at 1 month, by an average of 4 lines. The average intermediate UCVA for each group was 20/32. Both groups had an average improvement of 1 line distance UCVA though two subjects lost one line of distance vision. The average distance UCVA for each group was 20/25. There was no statistically significant difference between the two groups’ task performance and patient satisfaction at the 1 month post-op visit.

Conclusions: : The ReVision Optics corneal inlay is an effective tool to improve near vision in hyperopic presbyopes up to at least +1.75 D MRSE and post-op visual acuities and function are little affected by pre-op MRSE in the range of +0.50 to +1.75 D.*CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.

Keywords: cornea: clinical science • presbyopia • refractive surgery