Back to resultsTopical Bromfenac for Intraoperative Miosis and Pain Reduction
Primary Purpose
Cataract
Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
0,09% Bromfenac
0,1% sodium hyaluronate
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Phacoemulsification, femtosecond laser, bromfenac, NSAID, pupil
Eligibility Criteria
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
Sites / Locations
- Maria Camila Aguilar Sierra
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
0,09% Bromfenac
0,1% sodium hyaluronate
Arm Description
Topical 0,09% Bromfenac twice daily 3 days before surgery
Topical 0,1% sodium hyaluronate twice daily 3 days before surgery
Outcomes
Primary Outcome Measures
intraoperative miosis
Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery
Secondary Outcome Measures
postoperative pain
Evaluation of reduction of postoperative pain using a visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03831984
Brief Title
Topical Bromfenac for Intraoperative Miosis and Pain Reduction
Official Title
Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
March 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de La Luz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Phacoemulsification, femtosecond laser, bromfenac, NSAID, pupil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0,09% Bromfenac
Arm Type
Active Comparator
Arm Description
Topical 0,09% Bromfenac twice daily 3 days before surgery
Arm Title
0,1% sodium hyaluronate
Arm Type
Placebo Comparator
Arm Description
Topical 0,1% sodium hyaluronate twice daily 3 days before surgery
Intervention Type
Drug
Intervention Name(s)
0,09% Bromfenac
Other Intervention Name(s)
Zebesten
Intervention Description
topical 0,09% Bromfenac, one drop twice daily 3 days before surgery
Intervention Type
Drug
Intervention Name(s)
0,1% sodium hyaluronate
Other Intervention Name(s)
Hyabak
Intervention Description
topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery
Primary Outcome Measure Information:
Title
intraoperative miosis
Description
Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery
Time Frame
2 days
Secondary Outcome Measure Information:
Title
postoperative pain
Description
Evaluation of reduction of postoperative pain using a visual analogue scale
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA AGUILAR SIERRA, MD
Organizational Affiliation
FELLOWSHIP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Camila Aguilar Sierra
City
Ciudad de Mexico
ZIP/Postal Code
06030
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Bromfenac for Intraoperative Miosis and Pain Reduction
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