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
1 other identifier
interventional
337
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2003
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 16, 2010
CompletedFirst Posted
Study publicly available on registry
July 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
September 28, 2018
CompletedSeptember 28, 2018
August 1, 2018
11.3 years
July 16, 2010
January 9, 2017
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
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.
From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Secondary Outcomes (1)
Presence of Significant Safety Events (SAEs).
From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Other Outcomes (6)
Safety Parameter Point Estimate -- Anterior Segment Ischemia
From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines
From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines
From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.
- +3 more other outcomes
Study Arms (3)
Implantation-Non Randomized
EXPERIMENTALSubjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
Implantation-Randomized
EXPERIMENTALSubjects 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.
Deferred Implantation-Randomized
NO INTERVENTIONSubjects 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.
Interventions
Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Boxer-Wachler Vision Institute
Beverly Hills, California, 90210, United States
Gordon-Weiss-Schanzlin Vision Institute
San Diego, California, 92122, United States
The Midwest Center for Sight
Des Plaines, Illinois, 60016, United States
Jacksoneye
Lake Villa, Illinois, 60046, United States
Vision/Advanced Eye Center
Lombard, Illinois, 60148, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Associated Vision Consultants
Southfield, Michigan, 48034, United States
Cornea Associates
Omaha, Nebraska, 68144, United States
Fichte, Endl and Elmer Eyecare Creekside Center
Amherst, New York, 14228, United States
Southeastern Eye Center
Greensboro, North Carolina, 27410, United States
Eye Associates of South Tulsa
Tulsa, Oklahoma, 74133, United States
Wang Vision Institute
Nashville, Tennessee, 37203, United States
Braverman-Terry-Oei-Eye Associates
San Antonio, Texas, 78212, United States
The Center for Corrective Eye Surgery
San Antonio, Texas, 78215, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Regulatory & Quality
- Organization
- Refocus Group, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
David Schanzlin, M.D.
Chief Medical Officer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2010
First Posted
July 21, 2010
Study Start
December 1, 2003
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
September 28, 2018
Results First Posted
September 28, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share