Clinical Trial: A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near and Intermediate Vision in Pseudophakic Presbyopic Subjects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ReVision Optics, Inc., RAINDROP® NEAR VISION INLAY for the Improvement of Near and Intermediate Vision in

Brief Summary: The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and intermediate vision.

Detailed Summary:

The loss of near vision and the ability to perform tasks that require near vision is part of the normal aging process. This natural transformation in the eye occurs as a result of the loss of accommodation of the crystalline lens, a condition known as presbyopia. Presbyopia, characterized by a progressive, age-related loss of accommodation (i.e., the lens ability to focus clearly over a wide range of distances), is most prevalent of all visual deficiencies, affecting 100% of the population over the course of a normal life span.

Presbyopia is also a natural outcome of pseudophakic subjects with monofocal or toric intraocular lenses. Treatment of pseudophakic presbyopia generally consists of reading glasses, contact lenses, or monovision LASIK which allows the patient to see near objects. All these options present limitations from the patient perspective.

ReVision Optics has developed the Raindrop corneal inlay for the correction of near vision. The Raindrop is a 2mm corneal inlay, as small as a pinhead, thinner than a human hair and about 1/500th of a droplet of water. The inlay is the same refractive index as the human cornea. The inlay is placed in the non-dominant eye, centered over the pupil after a corneal flap or corneal pocket has been made. The Raindrop is expected to provide pseudophakic presbyopic subjects with improvement of near and intermediate vision.

Sponsor: ReVision Optics, Inc.

Current Primary Outcome:

• Improvement in uncorrected near visual acuity [ Time Frame: 24 Months ]
  Seventy-five percent of eyes should achieve uncorrected near visual acuity of 20/40 or better.
• Preservation of best corrected visual acuity [ Time Frame: 24 Months ]
  Fewer than five percent of eyes should lose more than 2 lines of best corrected distance visual acuity after implantation

Original Primary Outcome:

Current Secondary Outcome:

• Improvement in uncorrected intermediate visual acuity [ Time Frame: 24 Months ]
  Seventy-five percent of eyes should achieve uncorrected intermediate visual acuity of 20/40 or better (measured at 80cm/32 inches)
• Adverse Events [ Time Frame: 24 Months ]
  Adverse events should occur in less than 10% of eyes and any single adverse event should occur in less than 2.5% of eyes.

Original Secondary Outcome:

Information By: ReVision Optics, Inc.

Dates:
Date Received: January 26, 2016
Date Started: December 2015
Date Completion: July 2018
Last Updated: January 6, 2017
Last Verified: January 2017