Topical Bromfenac for Intraoperative Miosis and Pain Reduction

Sponsor

Hospital de La Luz (Other)

Overall Status

Unknown status

CT.gov ID

NCT03831984

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: 0,09% Bromfenac Drug: 0,1% sodium hyaluronate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Nov 30, 2018

Anticipated Study Completion Date :

Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 0,09% Bromfenac Topical 0,09% Bromfenac twice daily 3 days before surgery	Drug: 0,09% Bromfenac topical 0,09% Bromfenac, one drop twice daily 3 days before surgery Other Names: Zebesten
Placebo Comparator: 0,1% sodium hyaluronate Topical 0,1% sodium hyaluronate twice daily 3 days before surgery	Drug: 0,1% sodium hyaluronate topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery Other Names: Hyabak

Arm

Intervention/Treatment

Active Comparator: 0,09% Bromfenac

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

Drug: 0,09% Bromfenac

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

Other Names:

Zebesten

Placebo Comparator: 0,1% sodium hyaluronate

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

Drug: 0,1% sodium hyaluronate

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

Other Names:

Hyabak

Outcome Measures

Primary Outcome Measures

intraoperative miosis [2 days]
Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery

Secondary Outcome Measures

postoperative pain [1 day]
Evaluation of reduction of postoperative pain using a visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.