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

February 21, 2019 updated by: Omnia Ahmed Mahrous Sayed, Assiut University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nepafenac and cyclopentolate
Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Drug: Nepafenac Ophthalmic
Preoperative administration of Nepafenac 1 mg eye drops
Drug: Cyclopentolate Ophthalmic
Preoperative administration of Cyclopentolate eye drops
Experimental: Ketorolac and cyclopentolate
Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery
Drug: Cyclopentolate Ophthalmic
Preoperative administration of Cyclopentolate eye drops
Drug: Ketorolac Ophthalmic
Preoperative administration of Ketorolac 0.5% eye drops
Placebo Comparator: Cyclopentolate and saline 0.9%
Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery
Drug: Cyclopentolate Ophthalmic
Preoperative administration of Cyclopentolate eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

March 30, 2020

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0925-0586

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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