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

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 31, 2012
Last Updated Date	January 2, 2013
Start Date ^ICMJE	January 2012
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 2, 2013)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01761071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Myopes Who Have Undergone PRK.
Intervention ^ICMJE	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. 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.
Study Arm (s)	Experimental: group KO (ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye) Intervention: Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) Active Comparator: group DO (diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye) Intervention: Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	94
Completion Date	December 2012
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01761071
Other Study ID Numbers ^ICMJE	4-2012-0440
Has Data Monitoring Committee	No
Responsible Party	Yonsei University
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top