Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

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%
    

Intervention name(s): PresVIEW Scleral Implants
Intervention type(s): Device
Intervention description(s): Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Presbyopia; Reading Vision; Near Vision