Topical Bromfenac for Intraoperative Miosis and Pain Reduction

Hospital de La Luz

Status and phase: Unknown; Phase 4

Conditions: Cataract

Treatments: Drug: 0,09% Bromfenac; Drug: 0,1% sodium hyaluronate

Study type: Interventional

Funder types: Other

Identifiers

NCT03831984

MAguilarSierra

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

0,09% Bromfenac

Active Comparator group

Description:

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

Treatment:

Drug: 0,09% Bromfenac

0,1% sodium hyaluronate

Placebo Comparator group

Description:

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

Treatment:

Drug: 0,1% sodium hyaluronate