Topical Bromfenac for Intraoperative Miosis and Pain Reduction

Phase 4

• Conditions: Cataract
• Interventions: Drug: 0,1% sodium hyaluronate; Drug: 0,09% Bromfenac

• Registration Number: NCT03831984
• Lead Sponsor: Hospital de La Luz

Brief Summary

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

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 Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-11-30
• Status Verified: 2019-02
• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-04
• Last Update Submitted: 2019-02-04
• Study First Posted: 2019-02-06
• Last Update Posted: 2019-02-06
• Study Completion: 2019-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0,1% sodium hyaluronate	0,1% sodium hyaluronate	Topical 0,1% sodium hyaluronate twice daily 3 days before surgery
0,09% Bromfenac	0,09% Bromfenac	Topical 0,09% Bromfenac twice daily 3 days before surgery

Primary Outcome Measures

Name	Time	Method
intraoperative miosis	2 days	Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery

Secondary Outcome Measures

Name	Time	Method
postoperative pain	1 day	Evaluation of reduction of postoperative pain using a visual analogue scale

Trial Locations

Locations (1)

Maria Camila Aguilar Sierra; 🇲🇽 Ciudad de Mexico, Mexico