Topical Bromfenac for Intraoperative Miosis and Pain Reduction

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03831984
• Other study ID #: MAguilarSierra
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: February 2019
• Source: Hospital de La Luz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: March 30, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• 0,09% Bromfenac
topical 0,09% Bromfenac, one drop twice daily 3 days before surgery
• 0,1% sodium hyaluronate
topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery

Locations

Country	Name	City	State
Mexico	Maria Camila Aguilar Sierra	Ciudad de Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de La Luz

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative miosis	Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery	2 days
Secondary	postoperative pain	Evaluation of reduction of postoperative pain using a visual analogue scale	1 day