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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01761071
First received: December 31, 2012
Last updated: January 2, 2013
Last verified: January 2013

December 31, 2012
January 2, 2013
January 2012
November 2012   (final data collection date for primary outcome measure)
Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes. [ Time Frame: Change the VAS level at 6, 18, 24, 36, 48, 72, and 96 hours after ketorolac in photorefractive keratectomy(PRK) ] [ Designated as safety issue: No ]
Through these postoperative pain score which rated time serially, the effect of pre-treated topical NSAIDs(ketorolac and diclofenac) could be investigated on relieving postoperative pain after PRK.
Same as current
Complete list of historical versions of study NCT01761071 on ClinicalTrials.gov Archive Site
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Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Myopes Who Have Undergone PRK.
  • 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.
  • Experimental: group KO
    (ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye)
    Intervention: Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)
  • Active Comparator: group DO
    (diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye)
    Intervention: Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
December 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. at least 19 years of age
  2. simultaneous bilateral PRK schedule
  3. more than 400μm(including epithelium) of postoperative corneal thickness
  4. less than 150μm of ablation depth.

Exclusion Criteria:

  1. a history of ocular surgery or trauma
  2. two-diopter more difference in spherical equivalent (SE) between the eyes, 3. keratoconus or other corneal pathology

4. use of systemic or topical NSAID within 1 month before the surgery 5. history of allergic reaction to aspirin or other NSAIDs 6. glaucoma or ocular hypertension (> 20 mmHg) 7. collagen vascular diseases 8. diabetic retinopathy 9. pregnancy or lactation 10. intraoperative complications.

Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01761071
4-2012-0440
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP