Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
Primary Purpose
Cataract, Miosis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ketorolac Ophthalmic
Nepafenac Ophthalmic
Cyclopentolate Ophthalmic
Sponsored by
About this trial
This is an interventional prevention trial for Cataract focused on measuring Cataract surgery, Intraoperative Miosis, Ketorolac eye drops, Nepafenac eye drops
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Nepafenac and cyclopentolate
Ketorolac and cyclopentolate
Cyclopentolate and saline 0.9%
Arm Description
Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery
Outcomes
Primary Outcome Measures
Prevention of miosis during cataract surgery
The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03851172
Brief Title
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
Official Title
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Miosis
Keywords
Cataract surgery, Intraoperative Miosis, Ketorolac eye drops, Nepafenac eye drops
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nepafenac and cyclopentolate
Arm Type
Experimental
Arm Description
Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Arm Title
Ketorolac and cyclopentolate
Arm Type
Experimental
Arm Description
Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Arm Title
Cyclopentolate and saline 0.9%
Arm Type
Placebo Comparator
Arm Description
Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery
Intervention Type
Drug
Intervention Name(s)
Ketorolac Ophthalmic
Intervention Description
Preoperative administration of Ketorolac 0.5% eye drops
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic
Intervention Description
Preoperative administration of Nepafenac 1 mg eye drops
Intervention Type
Drug
Intervention Name(s)
Cyclopentolate Ophthalmic
Intervention Description
Preoperative administration of Cyclopentolate eye drops
Primary Outcome Measure Information:
Title
Prevention of miosis during cataract surgery
Description
The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
We'll reach out to this number within 24 hrs