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

Phase 3

Completed

• Conditions: Myopes Who Have Undergone PRK.
• Interventions: Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA); Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)

• Registration Number: NCT01761071
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Study First Submitted: 2012-12-31
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-02
• Last Update Submitted: 2013-01-02
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

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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

3. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group KO	topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)	(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye)
group DO	topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)	(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye)

Primary Outcome Measures

Name	Time	Method
Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes.	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.

Trial Locations

Locations (1)

Departement of Ophthalmology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of