Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery

Study Overview
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Brief Summary
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This study aim at determining the efficacy of Nepafenac and Ketorolac in obtaining adequate intraoperative mydriasis and preventing miosis during cataract surgery. It also compare the efficacy of both Nepafenac versus Ketorolac, and determine the more effective agent in preventing miosis during cataract surgery. The investigators try to determine if the effect of preoperative NSAIDs agents use would show a financial benefit, or this manoeuvre would add a financial load on the patients who are candidate for cataract surgery.

Detailed Description
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Maintaining adequate mydriasis is one of the most important prerequisites during both extracapsular cataract extraction and phacoemulsification intervention. The importance of intraoperative maintenance of mydriasis arises from the necessity for the surgeon to insert intra-ocular lens in the posterior chamber of the eye. It is now well established that non-steroidal anti-inflammatory drugs (NSAIDs) reduce intraoperative miosis during cataract surgery. Topical Flurbiprofen, Indomethacin and Diclofenac with and without intraoperative epinephrine are the commonest topical non-steroidal eye drops with which nearly all publications in the literature studied the prevention of intraoperative surgery-induced miosis. In addition, Diclofenac was found to be the most effective NSAIDs agent in maintaining intraoperative mydriasis. More recently, evidence that some NSAIDs, namely ketorolac and Flurbiprofen, may have a role in preventing pseudophakic cystoid macular oedema. Patients whom eyes are pre-treated with some NSAIDs, especially diclofenac, shows a statistically significant reduction in the degree of postoperative inflammation (e.g., redness, pain and itching) on the first post-operative day. On the contrary, Thaller et al found, in his study at 2000, that no statistically significant difference in the postoperative redness, pain and cells in the anterior chamber. Administration of Adrenalin in the anterior chamber fluid is found by several studies to be more effective in maintaining intraoperative mydriasis than preoperative treatment with NSAIDs.

Official Title
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Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery

Conditions
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Cataract, Miosis

Intervention / Treatment
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* Drug: Ketorolac Ophthalmic
* Drug: Nepafenac Ophthalmic
* Drug: Cyclopentolate Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cataract who are candidate for cataract surgery Exclusion Criteria: D.M, Patient with other ocular comorbidities rather than cataract, Patients with history of trauma. Patients on Corticosteroid drops treatment. Previous intraocular surgery.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nepafenac and cyclopentolate<br>Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery | Drug: Nepafenac Ophthalmic<br>* Preoperative administration of Nepafenac 1 mg eye drops<br>Drug: Cyclopentolate Ophthalmic<br>* Preoperative administration of Cyclopentolate eye drops<br>|
| Experimental: Ketorolac and cyclopentolate<br>Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery | Drug: Ketorolac Ophthalmic<br>* Preoperative administration of Ketorolac 0.5% eye drops<br>Drug: Cyclopentolate Ophthalmic<br>* Preoperative administration of Cyclopentolate eye drops<br>|
| Placebo Comparator: Cyclopentolate and saline 0.9%<br>Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery | Drug: Cyclopentolate Ophthalmic<br>* Preoperative administration of Cyclopentolate eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of miosis during cataract surgery | The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract surgery, Intraoperative Miosis, Ketorolac eye drops, Nepafenac eye drops