Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)
This study has been completed.
Sponsor:
Yonsei University
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myopes Who Have Undergone PRK. |
Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
Resource links provided by NLM:
Drug Information available for:
Lactitol
Diclofenac sodium
Diclofenac potassium
Diclofenac
Ketorolac
Ketorolac tromethamine
Ofloxacin
U.S. FDA Resources
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- 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.
| Enrollment: | 94 |
| Study Start Date: | January 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: group KO
(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye)
|
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.
|
|
Active Comparator: group DO
(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye)
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- at least 19 years of age
- simultaneous bilateral PRK schedule
- more than 400μm(including epithelium) of postoperative corneal thickness
- less than 150μm of ablation depth.
Exclusion Criteria:
- a history of ocular surgery or trauma
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01761071 History of Changes |
| Other Study ID Numbers: | 4-2012-0440 |
| Study First Received: | December 31, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Diclofenac Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013