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Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy

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ClinicalTrials.gov Identifier: NCT00917657
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Sponsor:
Information provided by:
University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperopia Procedure: Photorefractive keratectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy
Study Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Newton Kara-José, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00917657    
Other Study ID Numbers: 1183/07
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 10, 2009
Last Verified: June 2009
Keywords provided by University of Sao Paulo:
photorefractive keratectomy
hyperopia
radial keratotomy
refractive surgery
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases