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

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.

Study Overview

• Status: Unknown
• Conditions: Cataract; Miosis
• Intervention / Treatment: Drug: Nepafenac Ophthalmic; Drug: Cyclopentolate Ophthalmic; Drug: Ketorolac Ophthalmic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 30, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Cataract surgery; Intraoperative Miosis; Ketorolac eye drops; Nepafenac eye drops
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Lens Diseases; Pupil Disorders; Cataract; Miosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Mydriatics; Ketorolac; Cyclopentolate; Nepafenac
• Other Study ID Numbers: 0925-0586

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No