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Clinical Trials/NCT03851172
NCT03851172
Unknown
Phase 2

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

Assiut University0 sites75 target enrollmentMarch 1, 2019

Overview

Phase
Phase 2
Intervention
Nepafenac Ophthalmic
Conditions
Cataract
Sponsor
Assiut University
Enrollment
75
Primary Endpoint
Prevention of miosis during cataract surgery
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
March 30, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omnia Ahmed Mahrous Sayed

Resident at ophthalmology department

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Patients with cataract who are candidate for cataract surgery

Exclusion Criteria

  • Patient with other ocular comorbidities rather than cataract,
  • Patients with history of trauma.
  • Patients on Corticosteroid drops treatment.
  • Previous intraocular surgery.

Arms & Interventions

Nepafenac and cyclopentolate

Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

Intervention: Nepafenac Ophthalmic

Nepafenac and cyclopentolate

Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

Intervention: Cyclopentolate Ophthalmic

Ketorolac and cyclopentolate

Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

Intervention: Ketorolac Ophthalmic

Ketorolac and cyclopentolate

Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

Intervention: Cyclopentolate Ophthalmic

Cyclopentolate and saline 0.9%

Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery

Intervention: Cyclopentolate Ophthalmic

Outcomes

Primary Outcomes

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

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