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Trial record 89 of 514 for:    KETOROLAC

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03851172
Recruitment Status : Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : February 25, 2019
Information provided by (Responsible Party):
Omnia Ahmed Mahrous Sayed, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Miosis Drug: Ketorolac Ophthalmic Drug: Nepafenac Ophthalmic Drug: Cyclopentolate Ophthalmic Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Allocation concealment will be achieved by masking the bottles of the different agents which will be used in the study. All agents will be added to non-labeled bottles, then they will be labeled by the supervisor (who will not participate in eye drops administration) as bottle (1), bottle (2) and bottle (3). The most junior researcher will be responsible for the eye drops administration, for whom the different agents are not known.
Primary Purpose: Prevention
Official Title: Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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: Ketorolac Ophthalmic
Preoperative administration of Ketorolac 0.5% eye drops

Drug: Cyclopentolate Ophthalmic
Preoperative administration of Cyclopentolate 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

Primary Outcome Measures :
  1. Prevention of miosis during cataract surgery [ Time Frame: 30 minutes ]
    The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Omnia Ahmed Mahrous Sayed, Resident at ophthalmology department, Assiut University Identifier: NCT03851172    
Other Study ID Numbers: 0925-0586
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omnia Ahmed Mahrous Sayed, Assiut University:
Cataract surgery
Intraoperative Miosis
Ketorolac eye drops
Nepafenac eye drops
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Pupil Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents