Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy

Hyperopia Clinical Trial

Official title:

Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917657
• Other study ID #: 1183/07
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: June 9, 2009
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperopia

Intervention

Procedure:
• Photorefractive keratectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo