Topical 0.1% Bromfenac Sodium and Prostaglandin E2 Inhibition in Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.1% bromfenac ophthalmic solution
femtosecond laser cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- if they were 50 years of age or older and were scheduled to undergo femtosecond laser cataract surgery
Exclusion Criteria:
- a previous history of intraocular surgery;
- recent trauma;
- uveitis;
- systemic disease, such as diabetes mellitus; hypertension;
- the use of systemic or topical NSAIDs within 1 week of enrollment.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
0.1% bromfenac ophthalmic solution
control physiological normal saline
Arm Description
Patients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery.
Patients received control physiological normal saline twice a day for 3 days before surgery.
Outcomes
Primary Outcome Measures
Pupil area measured using ImageJ software A
PGE2 levels measured with an enzyme-linked immunoassay
Secondary Outcome Measures
Full Information
NCT ID
NCT02681679
First Posted
February 10, 2016
Last Updated
February 11, 2016
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China
1. Study Identification
Unique Protocol Identification Number
NCT02681679
Brief Title
Topical 0.1% Bromfenac Sodium and Prostaglandin E2 Inhibition in Cataract Surgery
Official Title
Topical 0.1% Bromfenac Sodium for Intraoperative Pupil Dilation Maintenance and Prostaglandin E2 Inhibition in Femtosecond Laser-assisted Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Since a new generation of femtosecond lasers became available for cataract surgery in 2009, the use of this image-guided system has provided several benefits, including a reduction in phacoemulsification energy by prefragmentation of the crystalline lens, and the potential advantages of more precise corneal incisions and capsulotomy formation. However, as with any new surgical technique, femtosecond laser cataract surgery also has potential complications. Intraoperative miosis is one of the most common intraoperative complications of femtosecond laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%.8 Significant pupillary constriction necessitates the removal of the anterior capsule flap, fragmented nucleus and remaining cortex, which is potentially associated with a higher rate of surgery-related complications.
Detailed Description
Since a new generation of femtosecond lasers became available for cataract surgery in 2009, the use of this image-guided system has provided several benefits, including a reduction in phacoemulsification energy by prefragmentation of the crystalline lens, and the potential advantages of more precise corneal incisions and capsulotomy formation. However, as with any new surgical technique, femtosecond laser cataract surgery also has potential complications. Intraoperative miosis is one of the most common intraoperative complications of femtosecond laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%. Significant pupillary constriction necessitates the removal of the anterior capsule flap, fragmented nucleus and remaining cortex, which is potentially associated with a higher rate of surgery-related complications.
Intraoperative miosis may be due to the intraocular effects that occur after femtosecond laser pretreatment. The intraocular tissues may be exposed to laser emissions, and lens proteins can be released into the anterior chamber. Together, these events trigger the release of unwanted cytokines. In a previous study, intraocular prostaglandin concentrations were found to be increased immediately after femtosecond laser pretreatment. Prostaglandins, especially prostaglandin E2 (PGE2), are known to play a role in inflammation-induced miosis.
Preoperative topical treatment with NSAIDs inhibits the release of prostaglandins in response to surgically-induced miosis by suppressing cyclooxygenase, the enzyme that transforms arachidonic acid into prostaglandin precursors. The effectiveness of ophthalmic NSAIDs in preventing miosis has been well documented in conventional phacoemulsification cataract surgery. However, whether this effect is also applicable to femtosecond laser-assisted cataract surgery is unknown. Yeoh has suggested the addition of NSAID eye drops to the dilation regimen during femtosecond laser cataract surgery, but no randomized study has been conducted to support this theory. Given the increasing popularity of femtosecond laser-assisted cataract surgery, the investigators sought to study whether topical NSAIDs might be beneficial in pupil maintenance and PGE2 inhibition during the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.1% bromfenac ophthalmic solution
Arm Type
Experimental
Arm Description
Patients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery.
Arm Title
control physiological normal saline
Arm Type
Placebo Comparator
Arm Description
Patients received control physiological normal saline twice a day for 3 days before surgery.
Intervention Type
Drug
Intervention Name(s)
0.1% bromfenac ophthalmic solution
Intervention Type
Procedure
Intervention Name(s)
femtosecond laser cataract surgery
Primary Outcome Measure Information:
Title
Pupil area measured using ImageJ software A
Time Frame
surgery
Title
PGE2 levels measured with an enzyme-linked immunoassay
Time Frame
2 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
if they were 50 years of age or older and were scheduled to undergo femtosecond laser cataract surgery
Exclusion Criteria:
a previous history of intraocular surgery;
recent trauma;
uveitis;
systemic disease, such as diabetes mellitus; hypertension;
the use of systemic or topical NSAIDs within 1 week of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D. Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
20000286
Citation
Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04.
Results Reference
background
Links:
URL
http://www.gzzoc.com/
Description
Home page of Zhongshan Ophthalmic Center
Learn more about this trial
Topical 0.1% Bromfenac Sodium and Prostaglandin E2 Inhibition in Cataract Surgery
We'll reach out to this number within 24 hrs