NCT01373580

A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients

A Prospective, Multinational Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ReVision Optics, Inc. PresbyLens Corneal Inlay for the Improvement of Near Vision in Presbyopic Subjects With MRSE From -0.50 to +1.00

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: ReVision Optics, Inc. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study.

Detailed description

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. Loss of accommodation begins early in life and, for an emmetropic eye, generally culminates in a complete loss of functional near vision. 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 (LASIK)has been made. The Raindrop is expected to provide presbyopic subjects with improvement of near and intermediate vision.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	The Raindrop Near Vision Inlay	The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia

Timeline

• Start date: 2010-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2011-06-15
• Last updated: 2018-03-29
• Results posted: 2018-03-29

Locations

11 sites across 1 country: United States