Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)
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| ClinicalTrials.gov Identifier: NCT01761071 |
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Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
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Sponsor:
Yonsei University
Information provided by (Responsible Party):
Yonsei University
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Brief 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.
| Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 94 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Supportive Care |
| Study Start Date : | January 2012 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | December 2012 |
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| Arm | Intervention/treatment |
|---|---|
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Experimental: group KO
(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye)
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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. |
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Active Comparator: group DO
(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye)
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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. |
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) ]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.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761071
Locations
| Korea, Republic of | |
| Departement of Ophthalmology, Yonsei University College of Medicine | |
| Seoul, Korea, Republic of, 120-752 | |
Sponsors and Collaborators
Yonsei University
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01761071 |
| Other Study ID Numbers: |
4-2012-0440 |
| First Posted: | January 4, 2013 Key Record Dates |
| Last Update Posted: | January 4, 2013 |
| Last Verified: | January 2013 |
Additional relevant MeSH terms:
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Diclofenac Ketorolac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |