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Results from a multi-center US clinical trial for the surgical treatment of presbyopia

Poster Details

First Author: K.Stonecipher USA

Co Author(s):                  

Abstract Details



Purpose:

To assess the visual performance of emmetropic presbyopes after bilateral placement of PresVIEWTM Scleral Implants (PSI) in a multi-center clinical trial. This paper discusses the improvement in bilateral near and intermediate vision following this treatment.

Setting:

14 sites across the United States, in a controlled 2 year clinical trial.

Methods:

Three hundred and thirty (330) emmetropic presbyopes were enrolled in this study. All subjects met the pre-operative inclusion criteria of best corrected distance visual acuity (BCDVA) of 20/20, with a manifest refraction spherical equivalent (MRSE) between +0.75D and -0.50D, with ? 1.00D of astigmatism. Distance corrected near visual acuity (DCNVA) was between 20/50 and 20/100. During the bilateral procedure (each eye operated 2 weeks apart), four PSI were placed circumferentially in the oblique quadrants of the sclera, just posterior to the calculated lens equator. Bilateral improvement in unaided near and intermediate visual function was obtained subjectively using a questionnaire at the 3, 12 and 24 month study visits and compared with pre-operative responses; the descriptors ‘excellent’, ‘acceptable’ or ‘poor’ were used to describe their unaided vision.

Results:

The PSI procedure has been performed on 330 primary eyes and 315 fellow eyes (total N=645, mean pre-op DCNVA=20/73). The mean age of the cohort was 54.3 years. The mean MRSE of the cohort was +0.28D. To date, n=324 at 3 months, n=179 at 12 months and n=80 at 24 months. At 3 months, an improvement was seen in subjects reporting excellent-acceptable bilateral intermediate vision while viewing the computer improving to 87% vs. 24% pre-op. Similarly, an improvement was seen while reading newspapers improving to 76% vs. 4% pre-op; with 73% of subjects still rating excellent-acceptable vision at 24 months. Other fine near tasks such as reading prices and medicine labels also improved by 59% and 57% at 3 months, respectively. At 24 months, 83% of subjects are able to perform most near activities without reading spectacles, and 89% rate their near vision as better to significantly better when compared to before PSI treatment. Distance vision is not affected by this procedure, with 99% of subjects reporting excellent-acceptable vision for distance tasks (as they were pre-operatively).

Conclusions:

These preliminary results suggest that the PresVIEWTM Scleral Implant (PSI) device is effective in restoring near and intermediate vision in emmetropic presbyopes. The improvement in vision is bilateral and clinically significant by 3 months, maintained throughout 2 years. All patients maintain binocular distance vision as the procedure is performed away from the visual axis.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a competing company, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company

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