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A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System

NCT01699087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2019-09-30

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in subjects undergoing photorefractive keratectomy (PRK) treatment.

Conditions

  • Astigmatism
  • Myopia

Interventions

PROCEDURE

Photorefractive keratectomy (PRK)

In this corneal surgical procedure, the outer corneal epithelial layer will be removed, after which the corneal stroma will be reshaped by excimer laser ablation to reduce or eliminate refractive errors.

DEVICE

ALLEGRETTO WAVE EYE-Q excimer laser system

The ALLEGRETTO WAVE EYE-Q excimer laser system is used for corneal stroma reshaping during PRK surgery

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Manager, GCRA Surgical · Alcon, a Novartis Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-07-31
Completion
2015-07-31

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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 NCT01699087 on ClinicalTrials.gov