NCT03326869

A Study Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets

A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets With a Delayed or Non-Delayed Approach

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Eye Center of North Florida · Academic / Other
• Sex: All
• Age: 41 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes implanted in corneal pockets with a delayed or a non-delayed approach.

Detailed description

Patients must be presbyopic with a reading add from +1.5 to +2.5 D, and both emmetropes (MRSE from -0.5 to +0.5 D) as well as ametropes (requiring concurrent LASIK) are included in the investigation. In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day. In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Raindrop Near Vision Inlay	The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.

Timeline

• Start date: 2017-10-18
• Primary completion: 2018-10-23
• Completion: 2018-10-23
• First posted: 2017-10-31
• Last updated: 2020-08-10
• Results posted: 2020-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study