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

Yonsei University

Status and phase: Completed; Phase 3

Conditions: Myopes Who Have Undergone PRK.

Treatments: Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland); Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01761071

4-2012-0440

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 2 patient groups

group KO

Experimental group

Description:

(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye)

Treatment:

Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)

group DO

Active Comparator group

Description:

(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye)

Treatment:

Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)