NCT01166568

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Refocus Group, Inc. · Industry
• Sex: All
• Age: 50 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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%

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	PresVIEW Scleral Implants	Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

Timeline

• Start date: 2003-12-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-07-21
• Last updated: 2018-09-28
• Results posted: 2018-09-28

Locations

14 sites across 1 country: United States