Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia

A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients

The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.

The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with the PSI and followed for a period of 24 months at up to 14 clinical sites. An additional randomized sub-study was performed on 48 subjects with the PSI Second Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the observation/deferred implantation control arm. Subjects randomized to the deferred implantation control arm were eligible to receive the PSI after completion of the 6 months of observation in the study. All subjects interested in participating in the study were screened for eligibility, and informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible subjects were examined preoperatively to obtain a medical history and baseline ocular data. Effectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI procedure will be included in the study protocol: Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected) Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected) The PSI procedure will be defined as successful if a logMar equivalent to Snellen 20/40 or better (logMar 0.3) is achieved in ≥ 75% of patients or if 75% of patients realize an improvement ≥ 2 lines in distance corrected near visual acuity (DCNVA). For most patients, this will translate into the ability to read the majority of newspaper and magazine print without a near optical aid. Safety: Primary safety outcomes for safety will include: Incidence of anterior segment ischemia Decrease in Best Corrected Distance Visual Acuity (BCDVA) of more than 2 lines from baseline at 1-month or more postoperatively Decrease in best distance corrected near acuity (with add) of more than 2 lines from baseline at 1-month or more postoperatively Intraocular Pressure (IOP) increase > 10mm Hg over baseline or IOP > 25mm Hg after 1 Day postoperative Signs of chronic inflammation (e.g. uveitis or chronic conjunctival hyperemia) at 2 months or more postoperatively Increase in axial length of ≥ 0.20mm accompanied by a > 0.5 diopter myopic shift in manifest spherical equivalent distance refraction. Incidence of adverse events: total not to exceed 5%, and the incidence of each event should not exceed 1-2%

A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.

Subjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria.

Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.

Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group.

Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines

Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.

From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.

The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase > 10 mmHg) or (IOP > 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Inclusion Criteria: Subject must be between 50-60 years old Subject must have a best corrected distance visual acuity of 20/20 or better Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive). Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other. Subject must be phakic in the study eye Subject must be mentally competent to understand and comply with the requirements of the study. Subject must be able to provide written informed consent. Exclusion Criteria: Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye. Scleral thickness less than 530 μm in the operative eye/eyes. Any previous eye surgeries including cataract, LASIK, or Muscle surgery Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles. Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc. Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases Allergic to any medications used in the study. The patient may not have participated in a device clinical study for the operative eye within the last 3 months and may not have been implanted with PSI devices in this or any other study.