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Safety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simultaneous Laser Procedure

NCT01322919 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-05-20

No results posted yet for this study

Summary

By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.

This study will help us to answer 2 questions:

1. How accurately this combined technique corrects distance and near vision
2. Whether the correction is adequate to remove the complete need for supplementary near spectacles

Conditions

Interventions

PROCEDURE

Supracor

All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components. The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases. In addition to the treatment for the distance vision a central ablation component will be added to address the near vision.

Sponsors & Collaborators

  • Technolas Perfect Vision GmbH

    lead INDUSTRY

Principal Investigators

  • Enrique Barragan, M.D. · Laser Ocular Hidalgo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • Mexico

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 NCT01322919 on ClinicalTrials.gov