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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

2 Days - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 21, 2019
    Last Updated
    February 21, 2019
    Sponsor
    Assiut University
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    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

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