NCT03017612

A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects

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 Pseudophakic Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: ReVision Optics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of a hydrogel material, implanted under a lasik flap. Subjects must require reading add from +1.50 D to +2.50 D. Subjects must have a preoperative manifest refraction spherical equivalent of -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop Near Vision Inlay will be implanted in the non-dominant eye.

Detailed description

Presbyopia is 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 suffer limitations from the patient perspective. For example, reading glasses can easily be lost or not conveniently available. Multifocal contact lenses suffer from visual symptoms and instability due to potential rotation and movement of the contact lenses on the surface of the cornea. And, successful monovision is generally limited to patients with a history of successful use of contact lenses for monovision, and even in these eyes, monovision is associated with a substantial decrease in stereo acuity and contrast sensitivity. ReVision Optics has developed the Raindrop Near Vision Inlay for the correction of near and intermediate vision. 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 Near Vision Inlay is expected to provide low induction of visual symptoms and improvement of near and intermediate vision in emmetropic subjects with presbyopia. This technology may also demonstrate potential clinical utility in bilateral pseudophakic subjects.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Raindrop Near Vision Inlay	A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2017-01-11
• Last updated: 2018-03-01
• Results posted: 2018-03-01

Locations

6 sites across 1 country: United States