Topical Bromfenac for Intraoperative Miosis and Pain Reduction

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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0,09% Bromfenac

Topical 0,09% Bromfenac twice daily 3 days before surgery

Group Type ACTIVE_COMPARATOR

0,09% Bromfenac

Intervention Type DRUG

topical 0,09% Bromfenac, one drop twice daily 3 days before surgery

0,1% sodium hyaluronate

Topical 0,1% sodium hyaluronate twice daily 3 days before surgery

Group Type PLACEBO_COMPARATOR

0,1% sodium hyaluronate

Intervention Type DRUG

topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery

Interventions

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0,09% Bromfenac

topical 0,09% Bromfenac, one drop twice daily 3 days before surgery

Intervention Type DRUG

0,1% sodium hyaluronate

topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery

Intervention Type DRUG

Other Intervention Names

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Zebesten Hyabak

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes