CataractNCT02681679
Topical 0.1% Bromfenac Sodium and Prostaglandin E2 Inhibition in Cataract Surgery
A study testing 0.1% bromfenac ophthalmic solution and femtosecond laser cataract surgery in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- 0.1% bromfenac ophthalmic solution and femtosecond laser cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- if they were 50 years of age or older and were scheduled to undergo femtosecond laser cataract surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Topical 0.1% Bromfenac Sodium for Intraoperative Pupil Dilation Maintenance and Prostaglandin E2 Inhibition in Femtosecond Laser-assisted Cataract Surgery
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- 0.1% bromfenac ophthalmic solution, femtosecond laser cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% bromfenac ophthalmic solutionDrug
femtosecond laser cataract surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 0.1% bromfenac ophthalmic solution | Experimental | Patients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery. Receives: Drug: 0.1% bromfenac ophthalmic solution; Procedure: femtosecond laser cataract surgery |
| control physiological normal saline | Placebo comparator | Patients received control physiological normal saline twice a day for 3 days before surgery. Receives: Procedure: femtosecond laser cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil area measured using ImageJ software A
Measured: surgery
PGE2 levels measured with an enzyme-linked immunoassay
Measured: 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D. Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681679
- Sponsor's protocol ID
- CCPMOH2016-China-1
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2016
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20000286
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 0.1% Bromfenac Sodium for Intraoperative Pupil Dilation Maintenance and Prostaglandin E2 Inhibition in Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT02681679
- Acronym / sponsor ID
- CCPMOH2016-China-1
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1% bromfenac ophthalmic solution | Experimental | Drug: 0.1% bromfenac ophthalmic solution, Procedure: femtosecond laser cataract surgeryPatients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery. |
| control physiological normal saline | Placebo comparator | Procedure: femtosecond laser cataract surgeryPatients received control physiological normal saline twice a day for 3 days before surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- if they were 50 years of age or older and were scheduled to undergo femtosecond laser cataract surgery
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1% bromfenac ophthalmic solution | Drug | 0.1% bromfenac ophthalmic solution |
| femtosecond laser cataract surgery | Procedure or surgery | 0.1% bromfenac ophthalmic solution, control physiological normal saline |
Primary outcome
Pupil area measured using ImageJ software A
Time frame: surgery
PGE2 levels measured with an enzyme-linked immunoassay
Time frame: 2 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Background: PubMed 20000286Nagy 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.
- Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haotian Lin, M.D. Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.1% bromfenac ophthalmic solution and femtosecond laser cataract surgery in people with Cataract, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil area measured using ImageJ software A (time frame: surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.