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Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia

NCT01028378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2016-04-11

Study results available
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Summary

This purpose of this study is to evaluate the safety and effectiveness of a topography-based custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating myopia and hyperopia.

Conditions

  • Myopia
  • Hyperopia

Interventions

DEVICE

T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • WaveLight AG

    collaborator INDUSTRY

  • Clinical Research Consultants, Inc.

    lead INDUSTRY

Principal Investigators

  • Doyle Stulting, M.D., Ph.D. · Woolfson Eye Institute/Medical Monitor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-04-30

Countries

  • United States

Study Locations

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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 NCT01028378 on ClinicalTrials.gov