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

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ClinicalTrials.gov Identifier: NCT01166568
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Refocus Group, Inc.

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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: PresVIEW Scleral Implants Not Applicable

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%

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
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
Official Title: A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
Study Start Date : December 2003
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Implantation-Non Randomized
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.
Device: PresVIEW Scleral Implants
Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

Experimental: Implantation-Randomized
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.
Device: PresVIEW Scleral Implants
Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

No Intervention: Deferred Implantation-Randomized
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.



Primary Outcome Measures :
  1. Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines [ Time Frame: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years. ]
    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.


Secondary Outcome Measures :
  1. Presence of Significant Safety Events (SAEs). [ Time Frame: From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study. ]

    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.



Other Outcome Measures:
  1. Safety Parameter Point Estimate -- Anterior Segment Ischemia [ Time Frame: 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.

  2. Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines [ Time Frame: 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.


  3. Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines [ Time Frame: 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.


  4. Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg) [ Time Frame: 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.


  5. Safety Parameter Point Estimate -- Chronic Inflammation [ Time Frame: 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.


  6. Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE) [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166568


Locations
United States, California
Boxer-Wachler Vision Institute
Beverly Hills, California, United States, 90210
Gordon-Weiss-Schanzlin Vision Institute
San Diego, California, United States, 92122
United States, Illinois
The Midwest Center for Sight
Des Plaines, Illinois, United States, 60016
Jacksoneye
Lake Villa, Illinois, United States, 60046
Vision/Advanced Eye Center
Lombard, Illinois, United States, 60148
United States, Kentucky
The Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Michigan
Associated Vision Consultants
Southfield, Michigan, United States, 48034
United States, Nebraska
Cornea Associates
Omaha, Nebraska, United States, 68144
United States, New York
Fichte, Endl and Elmer Eyecare Creekside Center
Amherst, New York, United States, 14228
United States, North Carolina
Southeastern Eye Center
Greensboro, North Carolina, United States, 27410
United States, Oklahoma
Eye Associates of South Tulsa
Tulsa, Oklahoma, United States, 74133
United States, Tennessee
Wang Vision Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Braverman-Terry-Oei-Eye Associates
San Antonio, Texas, United States, 78212
The Center for Corrective Eye Surgery
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Refocus Group, Inc.
Investigators
Principal Investigator: David Schanzlin, M.D. Chief Medical Officer

Additional Information:
Responsible Party: Refocus Group, Inc.
ClinicalTrials.gov Identifier: NCT01166568     History of Changes
Other Study ID Numbers: P-277-5
First Posted: July 21, 2010    Key Record Dates
Results First Posted: September 28, 2018
Last Update Posted: September 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Refocus Group, Inc.:
Presbyopia
Reading Vision
Near Vision

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases