NCT03376412

A Study to Evaluate the Raindrop Near Vision Inlay Under Flap or Within Pocket

A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted Under a Corneal Flap or Within a Small-Incision Pocket

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Whitten Laser Eye · Academic / Other
• Sex: All
• Age: 40 Years – 70 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 under a corneal flap or within a small-incision pocket.

Detailed description

Patients must require a reading add from +1.5 to +2.5 D, and both emmetropes as well as ametropes (requiring concurrent LASIK) are included in the investigation. Suitable patients will undergo implantation of the Raindrop inlay in the non-dominant eye to improve near vision. If necessary, a LASIK excimer ablation will first be performed to optimize postoperative vision at near and distance. Patients will follow a one-month regimen of strong steroid, at a minimum, after corneal inlay implantation to facilitate healing and visual recovery.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Raindrop Near Vision Inlay	A maximum of 60 consecutive non-dominant eyes will be implanted with the Raindrop Near Vision Inlay.

Timeline

• Start date: 2017-12-08
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-12-18
• Last updated: 2017-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study