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

Completed · Not applicable

Conditions studied: Presbyopia

In brief

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.

Key facts

Study ID

NCT01166568

Run by

Refocus Group, Inc.

People needed

337

Starts

2003-12-01

Expected to finish

2015-03-01

Last updated by the study team

2018-09-28

Who can join

Age: 50 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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