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Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00917657
First received: June 9, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).


Condition Intervention
Hyperopia
 Procedure: Photorefractive keratectomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy

Further study details as provided by University of Sao Paulo:

Enrollment: 36
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
  • Uncorrected Visual Acuity of 20/40 or worse;
  • Best-Corrected Visual Acuity of 20/60 or better.

Exclusion Criteria:

  • Systemic or ocular conditions that could bias results
  • Previous photorefractive surgery
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Newton Kara-José, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00917657     History of Changes
Other Study ID Numbers: 1183/07
Study First Received: June 9, 2009
Last Updated: June 9, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
photorefractive keratectomy
hyperopia
radial keratotomy
refractive surgery

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013