Status:
COMPLETED
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
Lead Sponsor:
Refocus Group, Inc.
Conditions:
Presbyopia
Eligibility:
All Genders
50-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT01166568
Start Date
December 1 2003
End Date
March 1 2015
Last Update
September 28 2018
Active Locations (14)
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1
Boxer-Wachler Vision Institute
Beverly Hills, California, United States, 90210
2
Gordon-Weiss-Schanzlin Vision Institute
San Diego, California, United States, 92122
3
The Midwest Center for Sight
Des Plaines, Illinois, United States, 60016
4
Jacksoneye
Lake Villa, Illinois, United States, 60046