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

NCT ID: NCT01166568

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2015-03-31

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%

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PresVIEW Scleral Implants

Intervention Type: DEVICE

Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

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.

Group Type: EXPERIMENTAL

PresVIEW Scleral Implants

Intervention Type: DEVICE

Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PresVIEW Scleral Implants

Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Refocus Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Schanzlin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chief Medical Officer

Locations

Boxer-Wachler Vision Institute

Beverly Hills, California, United States

Gordon-Weiss-Schanzlin Vision Institute

San Diego, California, United States

The Midwest Center for Sight

Des Plaines, Illinois, United States

Jacksoneye

Lake Villa, Illinois, United States

Vision/Advanced Eye Center

Lombard, Illinois, United States

The Eye Care Institute

Louisville, Kentucky, United States

Associated Vision Consultants

Southfield, Michigan, United States

Cornea Associates

Omaha, Nebraska, United States

Fichte, Endl and Elmer Eyecare Creekside Center

Amherst, New York, United States

Southeastern Eye Center

Greensboro, North Carolina, United States

Eye Associates of South Tulsa

Tulsa, Oklahoma, United States

Wang Vision Institute

Nashville, Tennessee, United States

Braverman-Terry-Oei-Eye Associates

San Antonio, Texas, United States

The Center for Corrective Eye Surgery

San Antonio, Texas, United States

Countries

United States

Related Links

http://www.fda.gov

US Food and Drug Administration Website

Other Identifiers

P-277-5

Identifier Type: -

Identifier Source: org_study_id