Clinical trial NCT01166568: Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
Official title: A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Presbyopia
Reading Vision
Near Vision
Lead sponsor: Refocus Group, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 337
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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%

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
timeFrame: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Secondary outcomes:
measure: Presence of Significant Safety Events (SAEs).
timeFrame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Other outcomes:
measure: Safety Parameter Point Estimate -- Anterior Segment Ischemia
timeFrame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
measure: Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines
timeFrame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
measure: Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines
timeFrame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
measure: Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)
timeFrame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
measure: Safety Parameter Point Estimate -- Chronic Inflammation
timeFrame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
measure: Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)
timeFrame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Locations:
city: Beverly Hills
country: United States
facility: Boxer-Wachler Vision Institute
state: California
city: San Diego
country: United States
facility: Gordon-Weiss-Schanzlin Vision Institute
state: California
city: Des Plaines
country: United States
facility: The Midwest Center for Sight
state: Illinois
city: Lake Villa
country: United States
facility: Jacksoneye
state: Illinois
city: Lombard
country: United States
facility: Vision/Advanced Eye Center
state: Illinois
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Southfield
country: United States
facility: Associated Vision Consultants
state: Michigan
city: Omaha
country: United States
facility: Cornea Associates
state: Nebraska
city: Amherst
country: United States
facility: Fichte, Endl and Elmer Eyecare Creekside Center
state: New York
city: Greensboro
country: United States
facility: Southeastern Eye Center
state: North Carolina
city: Tulsa
country: United States
facility: Eye Associates of South Tulsa
state: Oklahoma
city: Nashville
country: United States
facility: Wang Vision Institute
state: Tennessee
city: San Antonio
country: United States
facility: Braverman-Terry-Oei-Eye Associates
state: Texas
city: San Antonio
country: United States
facility: The Center for Corrective Eye Surgery
state: Texas
Study officials:
affiliation: Chief Medical Officer
name: David Schanzlin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: