Topical Bromfenac for Intraoperative Miosis and Pain Reduction

February 4, 2019 updated by: Maria Camila Aguilar Sierra, Hospital de La Luz

Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery

To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Ciudad de Mexico, Mexico, 06030
        • Maria Camila Aguilar Sierra

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female
  • Subjects 18 years or older
  • Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.

Exclusion Criteria:

  • Presence of corneal abnormalities
  • History of intraocular surgery
  • History of ocular or systematic diseases (glaucoma, diabetes, uveitis
  • Regular, systemic use of steroid or NSAIDs during the previous 3 months

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 0,09% Bromfenac
Topical 0,09% Bromfenac twice daily 3 days before surgery
Drug: 0,09% Bromfenac
topical 0,09% Bromfenac, one drop twice daily 3 days before surgery
Other Names:
  • Zebesten
PLACEBO_COMPARATOR: 0,1% sodium hyaluronate
Topical 0,1% sodium hyaluronate twice daily 3 days before surgery
Drug: 0,1% sodium hyaluronate
topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery
Other Names:
  • Hyabak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative miosis
Time Frame: 2 days
Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: 1 day
Evaluation of reduction of postoperative pain using a visual analogue scale
1 day

Collaborators and Investigators

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

Sponsor

Hospital de La Luz

Investigators

  • Principal Investigator: MARIA AGUILAR SIERRA, MD, fellowship

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 (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

November 30, 2018

Study Completion (ANTICIPATED)

March 30, 2019

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (ACTUAL)

February 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAguilarSierra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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