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A Study Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets

NCT03326869 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-08-10

Study results available
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Summary

The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes implanted in corneal pockets with a delayed or a non-delayed approach.

Conditions

Interventions

DEVICE

Raindrop Near Vision Inlay

The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.

Sponsors & Collaborators

  • Eye Center of North Florida

    lead OTHER

Principal Investigators

  • Bret L. Fisher, MD · Eye Center of North Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2018-10-23
Completion
2018-10-23
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 NCT03326869 on ClinicalTrials.gov