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

Study Overview
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Brief Summary
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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
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Myopes Who Have Undergone PRK.

Intervention / Treatment
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* Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)
* Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group KO<br>(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye) | Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)<br>* 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.<br>|
| Active Comparator: group DO<br>(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye) | Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes. | 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. | Change the VAS level at 6, 18, 24, 36, 48, 72, and 96 hours after ketorolac in photorefractive keratectomy(PRK) |