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

NCT03242317 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-08-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fichte, Endl & Elmer Eyecare

    lead OTHER

Principal Investigators

  • Michael J Endl, MD · Fichte, Endl & Elmer Eyecare

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
41 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2020-09-01
Completion
2020-12-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242317 on ClinicalTrials.gov