Topical Bromfenac for Intraoperative Miosis and Pain Reduction

Study Overview
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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.

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.

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: 0,09% Bromfenac
* Drug: 0,1% sodium hyaluronate


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0,1% sodium hyaluronate<br>Topical 0,1% sodium hyaluronate twice daily 3 days before surgery | Drug: 0,1% sodium hyaluronate<br>* topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery<br>* Other names: Hyabak;|
| Active Comparator: 0,09% Bromfenac<br>Topical 0,09% Bromfenac twice daily 3 days before surgery | Drug: 0,09% Bromfenac<br>* topical 0,09% Bromfenac, one drop twice daily 3 days before surgery<br>* Other names: Zebesten;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative miosis | 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 | Evaluation of reduction of postoperative pain using a visual analogue scale | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phacoemulsification, femtosecond laser, bromfenac, NSAID, pupil