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

• ClinicalTrials.gov Identifier: NCT01761071
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Last Update Posted: January 4, 2013
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Study Description

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Korea, Republic of

Departement of Ophthalmology, Yonsei University College of Medicine

Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

More Information

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01761071 History of Changes
• Other Study ID Numbers: 4-2012-0440
• First Posted: January 4, 2013
• Last Update Posted: January 4, 2013
• Last Verified: January 2013

Additional relevant MeSH terms:

Ofloxacin; Levofloxacin; Diclofenac; Ketorolac; Ketorolac Tromethamine; Lactitol; 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; Cathartics; Gastrointestinal Agents; Anti-Infective Agents, Urinary; Anti-Infective Agents; Renal Agents; Anti-Bacterial Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors