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Session Title: New evaluation tools in refractive surgery
Session Date/Time: Sunday 06/10/2013 | 08:00-09:30
Paper Time: 08:27
Venue: Forum (Ground Floor)
First Author: : J.Katz USA
Co Author(s): : D. Schanzlin
To evaluate the effect on intraocular pressure (IOP) in normotensive patients after the placement of Scleral Implants, in a multi-center United States IDE clinical trial for the treatment of presbyopia.
14 sites across the United States, in a controlled 2 year clinical trial.
Three hundred and thirty (330) presbyopic emmetropes were recruited in this study. Primary eye eligibility criteria included: best corrected distance visual acuity (BCDVA) = 20/20; manifest refraction spherical equivalent (MRSE) between +0.75D and -0.50D, with ? 1.00D of astigmatism; distance corrected near visual acuity (DCNVA) between 20/50 and 20/100; and IOP of 23 mmHg or less. During the procedure, PresVIEW ScleraI Implants are placed in the primary eye, circumferentially in oblique quadrants of the sclera just posterior to the calculated lens equator. The fellow eye is implanted no sooner than 15 days following the primary eye. IOP readings were obtained using Goldmann applanation tonometry.
To date, the PresVIEW procedure has been performed on 645 eyes of 330 patients. Pre-operative unmedicated mean IOP was 14.7 mmHg (range 6-23 mmHg). Transient IOP elevation was observed one day post-operatively. The mean IOP in the normotensive cohort decreased at 6, 12, 18 and 24 months to 13.4 mmHg (-8.5%, n=595, range 6-22 mmHg), 12.9 mmHg (-11.8%, n=325, range 6-21 mmHg), 12.6 mmHg (-14.3%, n=213, range 6-19 mmHg), and 12.5 mmHg (-14.9%, n=132, range 6-20 mmHg), respectively. A second cohort included 115 eyes with pre-operative IOP of 18 to 23 mmHg. For this latter sub-group, transient IOP elevation was observed one day post-operatively. Mean IOP in this sub-group decreased at 6, 12, 18 and 24 months to 15.2 mmHg (-19.1%, n=107, range 821 mmHg), 14.2 mmHg (-24.6%, n=56, range 8-20 mmHg), 13.9 mmHg (-6.3%, n=34, range 8-19 mmHg), and 13.4 mmHg (-29.0%, n=24, range 8-18 mmHg) respectively.
These preliminary results suggest that the PresVIEW ScleraI Implants provide a reduction in IOP in normotensive eyes, over a two year period. To obtain data from ocular hypertensive (OHT) patients and those diagnosed with primary open angle glaucoma (POAG), a specifically designed clinical trial is currently underway in the UK.
... has significant investment interest in a company producing, developing or supplying product or procedure presented, ... 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 company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented
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