Topical Bromfenac for Intraoperative Miosis and Pain Reduction

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03831984

Enrollment

Registered

2019-02-06

Start date

2018-03-01

Completion date

2019-03-30

Last updated

2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Phacoemulsification, femtosecond laser, bromfenac, NSAID, pupil

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.

Interventions

DRUG0,09% Bromfenac

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

DRUG0,1% sodium hyaluronate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
postoperative pain	1 day	Evaluation of reduction of postoperative pain using a visual analogue scale

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026