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Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)

NCT01761071 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2013-01-04

No results posted yet for this study

Summary

The investigators performed this study to investigate pain prevention of preoperative topical nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK) using time serial pain scoring.

Conditions

  • Myopes Who Have Undergone PRK.

Interventions

DRUG

topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)

On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.

DRUG

topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)

On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • South Korea

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 NCT01761071 on ClinicalTrials.gov