NCT03242317

A Prospective Study to Evaluate the Raindrop Near Vision Inlay With Mitomycin C

A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Treated With Mitomycin C During Surgery and Extended Steroid After Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fichte, Endl & Elmer Eyecare · 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 treated with low dose, short duration Mitomycin C (MMC) during surgery and an extended low dose steroid regimen after surgery.

Detailed description

The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket. In the third month after surgical procedure, one-drop a day of low dose steroid will be continued for the duration of the 24-month follow-up period to maintain corneal health.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	Mitomycin C	The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.
DEVICE	Raindrop Near Vision Inlay	The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominant eye for the improvement of uncorrected near vision.

Timeline

• Start date: 2017-06-16
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2017-08-08
• Last updated: 2017-08-08

Locations

1 site across 1 country: United States

Regulatory

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