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

• ClinicalTrials.gov Identifier: NCT03851172
• Recruitment Status: Unknown
• First Posted: February 22, 2019
• Last Update Posted: February 25, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Omnia Ahmed Mahrous Sayed, Assiut University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

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

• 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:

Miosis; Cataract; Lens Diseases; Eye Diseases; Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Ketorolac; Nepafenac; Cyclopentolate; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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; Mydriatics; Autonomic Agents; Parasympatholytics; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents