MedTrace Logo

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

NCT03101501 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-08-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Key-Whitman Eye Center

    lead OTHER

Principal Investigators

  • Jeffrey Whitman, M.D. · Key-Whitman Eye Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
41 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2018-02-01
Completion
2018-02-01
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 NCT03101501 on ClinicalTrials.gov