A Phase 2 interventional study of Ketorolac Ophthalmic and Nepafenac Ophthalmic in Cataract and Miosis, sponsored by Assiut University. Status unknown. Open to participants aged 2 Days to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 75 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.
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Exclusion Criteria:
Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Drug: Nepafenac Ophthalmic · Drug: Cyclopentolate Ophthalmic
Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Drug: Ketorolac Ophthalmic · Drug: Cyclopentolate Ophthalmic
Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery
Drug: Cyclopentolate Ophthalmic
Preoperative administration of Ketorolac 0.5% eye drops
Preoperative administration of Nepafenac 1 mg eye drops
Preoperative administration of Cyclopentolate eye drops
Prevention of miosis during cataract surgery
The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate
Time frame: 30 minutes
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Miosis
Assiut University