NCT03101501

A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Key-Whitman Eye Center · Academic / Other
• Sex: All
• Age: 41 Years
• Healthy volunteers: Not accepted

Summary

The clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic or pseudophakic patients treated with low dose Mitomycin C immediately following femtosecond flap creation.

Detailed description

The scientific objective of this study is to evaluate the postoperative incidence of corneal reaction in patients treated with low dose Mitomycin C, immediately following femtosecond flap creation (LASIK correction if needed), and before implantation with the Raindrop corneal inlay in the non-dominant eye. The postoperative incidence of haze, visible by broad tangential illumination of the slit lamp, is known to adversely impact the safety and efficacy of the Raindrop corneal inlay. Three main strategies have been employed to minimize haze incidence after surgery: (i) perfection of the surgical technique, (ii) deeper implantation in the cornea, and (iii) extension of the steroid regimen after surgery. Haze has also been observed after another type of corneal refractive procedure, Photorefractive Keratectomy (PRK). Several prospective studies have shown that Mitomycin C, applied immediately following the PRK laser procedure, is effective in reducing the postoperative incidence of haze.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	Mitomycin c	Low dose mitomycin C at a concentration of 0.02% will be applied a duration of 10 to 30 seconds at the time of the surgical procedure.
DEVICE	Raindrop Near Vision Inlay	Implanted to improve near vision in Presbyopic or Pseudophakic subjects.

Timeline

• Start date: 2017-02-14
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2017-04-05
• Last updated: 2022-08-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study