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A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation

NCT03126877 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-07-14

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 presbyopic patients with treatments to optimize the ocular surface before corneal inlay surgery.

Conditions

Interventions

DRUG

Mitomycin C

The surgical procedure includes a low dose, short duration mitomycin C (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-dominante eye for the improvement of uncorrected near vision.

Sponsors & Collaborators

  • Whitten Laser Eye

    lead OTHER

Principal Investigators

  • Shilpa D Rose, MD · Whitten Laser Eye

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2020-09-30
Completion
2020-12-31
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 NCT03126877 on ClinicalTrials.gov