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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cataract Miosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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Nepafenac and cyclopentolate

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

Group Type EXPERIMENTAL

Nepafenac Ophthalmic

Intervention Type DRUG

Preoperative administration of Nepafenac 1 mg eye drops

Cyclopentolate Ophthalmic

Intervention Type DRUG

Preoperative administration of Cyclopentolate eye drops

Ketorolac and cyclopentolate

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

Group Type EXPERIMENTAL

Ketorolac Ophthalmic

Intervention Type DRUG

Preoperative administration of Ketorolac 0.5% eye drops

Cyclopentolate Ophthalmic

Intervention Type DRUG

Preoperative administration of Cyclopentolate eye drops

Cyclopentolate and saline 0.9%

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

Group Type PLACEBO_COMPARATOR

Cyclopentolate Ophthalmic

Intervention Type DRUG

Preoperative administration of Cyclopentolate eye drops

Interventions

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Ketorolac Ophthalmic

Preoperative administration of Ketorolac 0.5% eye drops

Intervention Type DRUG

Nepafenac Ophthalmic

Preoperative administration of Nepafenac 1 mg eye drops

Intervention Type DRUG

Cyclopentolate Ophthalmic

Preoperative administration of Cyclopentolate eye drops

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes