Trials / Unknown
UnknownNCT03831984
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Hospital de La Luz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 0,09% Bromfenac | topical 0,09% Bromfenac, one drop twice daily 3 days before surgery |
| DRUG | 0,1% sodium hyaluronate | topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2018-11-30
- Completion
- 2019-03-30
- First posted
- 2019-02-06
- Last updated
- 2019-02-06
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT03831984. Inclusion in this directory is not an endorsement.