Codeine Plus Paracetamol Versus Placebo for PRK Post-operative Pain

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Compare the use of codeine/paracetamol against placebo for pain control after cornea photorefractive keratectomy (PRK).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Acetaminophen; Codeine

Criteria

Inclusion Criteria:

• older than 20 years

• spherical component between -1.00 and -5.00, with or without astigmatism

• cylindrical component up to 1.5D

• spherical anisometropia of less than or equal to 0.75D,

• cylindrical anisometropia of less than or equal to 0.5D,

• stable refraction errors (maximal variation of 0.5D in the spherical or cylindrical component during 1 year)

• amenable to follow-up for at least seven (7) days.

Exclusion Criteria:

• presence of active disease of allergic, inflammatory or infectious nature, in the ocular surface or its attachments

• previous ocular history (pathology, surgery or ocular trauma)

• best corrected visual acuity less than 20/25)

• autoimmune disease, or immunosuppression or Diabetes Mellitus

• pregnancy or lactation.