CataractPhase 4NCT06785090
Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery
A Phase 4 study testing Bromfenac, Moxifloxacin 0.5% ophthalmic solution and Dexamethasone phosphate 0.1% in people with Cataract and Cystoid Macular Edema After Phacoemulsification, run by Inas Abd at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to learn if bromfenac ophthalmic solution can prevent cystoid macular edema (CME) and reduce macular thickness in patients undergoing phacoemulsification surgery for cataract removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Cystoid Macular Edema After Phacoemulsification
- What is being tested?
- Bromfenac, Moxifloxacin 0.5% ophthalmic solution and Dexamethasone phosphate 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteIraq
- Study dates
- 1 May 2023to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients 18 years of age and older.
- Patients diagnosed with cataracts.
Who cannot join
- Patients less than 18 years of age.
- Patients with glaucoma, ocular hypertension, pseudo-exfoliation syndrome, or any optic nerve disease.
- Patients with ocular diseases that might influence macular thickness, such as:
- Age-related macular degeneration
- Epiretinal membrane
- History of uveitis
Show all 17Show fewer
- Intraoperative complications
- Traumatic cases
- Patients who have undergone previous ocular surgery in the same eye, such as:
- Vitrectomy
- Intravitreal injection
- Retinal laser therapy
- Corneal surgery
- Patients who developed severe adverse effects from other drugs or had complications intraoperatively or postoperatively unrelated to bromfenac.
- Patients taking antiglaucoma medications.
- Patients lost to follow-up.
- Patients with an allergy to one of the postoperative medications.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Medicine, University of Baghdad
Baghdad, Baghdad Governorate, 10001
About this study
Official title: Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery
The goal of this clinical trial is to learn if bromfenac ophthalmic solution can prevent cystoid macular edema (CME) and reduce macular thickness in patients undergoing phacoemulsification surgery for cataract removal. The main questions it aims to answer are:
Does bromfenac reduce the incidence of CME after cataract surgery? Does bromfenac effectively control macular thickness postoperatively compared to standard care? investigators will compare the effects of bromfenac ophthalmic solution to a control group receiving standard postoperative treatment to see if bromfenac provides additional benefits.
Read more
Participants will:
Use bromfenac ophthalmic solution as prescribed postoperatively. Attend follow-up visits for macular thickness measurements and assessments of eye health.
Undergo routine postoperative evaluations to monitor for adverse effects.
Read the detailed description
The goal of this clinical trial is to investigate the effectiveness of bromfenac ophthalmic solution in preventing cystoid macular edema (CME) and reducing macular thickness in patients who have undergone cataract surgery using phacoemulsification. Cataract surgery, while generally safe, can sometimes lead to complications such as CME, a condition that causes swelling in the macula and may impair vision. Bromfenac, a non-steroidal anti-inflammatory drug (NSAID), is commonly used after cataract surgery to reduce inflammation and prevent such complications.
The main questions this study aims to answer are:
Can bromfenac ophthalmic solution effectively lower the risk of CME after cataract surgery? Does bromfenac help maintain or reduce macular thickness more effectively compared to standard postoperative care? Are there any significant side effects or risks associated with bromfenac use in this context? investigators will compare the outcomes of patients treated with bromfenac ophthalmic solution to those who receive standard postoperative treatment without bromfenac. This will help determine whether bromfenac provides superior protection against CME and better management of macular thickness.
Participant Involvement:
Participants will:
Use bromfenac ophthalmic solution as prescribed, Undergo detailed eye examinations, including macular thickness measurements, before surgery and during follow-up visits.
Be monitored for any side effects or adverse reactions to bromfenac during the study period.
Attend scheduled follow-up visits for assessments, which may include optical coherence tomography (OCT) imaging and visual acuity tests.
This study is focused on improving the understanding of bromfenac's role in postoperative eye care and helping optimize treatment protocols for cataract surgery patients to ensure better outcomes and prevent vision-related complications.
- Being tested
- Bromfenac, Moxifloxacin 0.5% ophthalmic solution, Dexamethasone phosphate 0.1%
- Keywords
- cataract, phacoemulsification, cystoid macular edema
- Medical subject headings
- Cataract, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromfenacDrug
Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) formulated as a 0.09% ophthalmic solution. It is administered to reduce inflammation and prevent cystoid macular edema (CME) following cataract surgery.
Moxifloxacin 0.5% ophthalmic solutionDrug
antibiotic, standard postoperative care regimen
Dexamethasone phosphate 0.1%Drug
steroid, standard postoperative care regimen
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac Group | Experimental | Participants in this group will receive bromfenac 0.09% ophthalmic solution as part of their postoperative care regimen following cataract surgery.
• Interventions: 0.09% bromfenac ophthalmic solution twice daily in addition to Moxifloxacin 0.5% ophthalmic drops every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs for six weeks Receives: Drug: Bromfenac; Drug: Moxifloxacin 0.5% ophthalmic solution; Drug: Dexamethasone phosphate 0.1% |
| Control Group | Active comparator | : Participants in this group will receive the standard postoperative care regimen without bromfenac.
• Interventions: Moxifloxacin 0.5% every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs for six weeks Receives: Drug: Moxifloxacin 0.5% ophthalmic solution; Drug: Dexamethasone phosphate 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery
This outcome measures the change in macular thickness in participants treated with bromfenac ophthalmic solution compared to the control group. Macular thickness was assessed using Optical Coherence Tomography (OCT) at two time points: preoperatively (baseline) and 6 weeks postoperatively.
The change was calculated as:
Macular Thickness at 6 Weeks Postoperative - Baseline Macular Thickness. A negative value indicates a decrease (thinning), while a positive value indicates an increase (thickening) in macular thickness.
Measured: 6 weeks postoperatively
Secondary outcomes (1)
Incidence of Adverse Events Related to Bromfenac
This outcome evaluates the safety of bromfenac ophthalmic solution by assessing the incidence of adverse events related to its use after cataract surgery. Adverse events include corneal erosion, irritation, and any other complications recorded during follow-up visits up to 6 weeks postoperatively
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 May 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inas Abd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inas Abd, University of Baghdad
- Investigators
- Zaid R Hussein, consultant ophthalmologist, Study director, Ibn Al Haitham eye teaching hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785090
- Sponsor's protocol ID
- ES-Bromphaco-2024
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2025
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, the plan to share individual participant data (IPD) is undecided. While the raw data from this study has been deposited in the public repository Zenodo to ensure accessibility, further decisions on sharing additional data or providing access to specific datasets will depend on future collaborations, publication requirements, and institutional guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery
- ClinicalTrials.gov ID
- NCT06785090
- Acronym / sponsor ID
- ES-Bromphaco-2024
- Keywords
- cataract, phacoemulsification, cystoid macular edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Inas AbdUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if bromfenac ophthalmic solution can prevent cystoid macular edema (CME) and reduce macular thickness in patients undergoing phacoemulsification surgery for cataract removal. The main questions it aims to answer are:
Does bromfenac reduce the incidence of CME after cataract surgery? Does bromfenac effectively control macular thickness postoperatively compared to standard care? investigators will compare the effects of bromfenac ophthalmic solution to a control group receiving standard postoperative treatment to see if bromfenac provides additional benefits.
Participants will:
Use bromfenac ophthalmic solution as prescribed postoperatively. Attend follow-up visits for macular thickness measurements and assessments of eye health.
Undergo routine postoperative evaluations to monitor for adverse effects.
Detailed description
The goal of this clinical trial is to investigate the effectiveness of bromfenac ophthalmic solution in preventing cystoid macular edema (CME) and reducing macular thickness in patients who have undergone cataract surgery using phacoemulsification. Cataract surgery, while generally safe, can sometimes lead to complications such as CME, a condition that causes swelling in the macula and may impair vision. Bromfenac, a non-steroidal anti-inflammatory drug (NSAID), is commonly used after cataract surgery to reduce inflammation and prevent such complications.
The main questions this study aims to answer are:
Can bromfenac ophthalmic solution effectively lower the risk of CME after cataract surgery? Does bromfenac help maintain or reduce macular thickness more effectively compared to standard postoperative care? Are there any significant side effects or risks associated with bromfenac use in this context? investigators will compare the outcomes of patients treated with bromfenac ophthalmic solution to those who receive standard postoperative treatment without bromfenac. This will help determine whether bromfenac provides superior protection against CME and better management of macular thickness.
Participant Involvement:
Participants will:
Use bromfenac ophthalmic solution as prescribed, Undergo detailed eye examinations, including macular thickness measurements, before surgery and during follow-up visits.
Be monitored for any side effects or adverse reactions to bromfenac during the study period.
Attend scheduled follow-up visits for assessments, which may include optical coherence tomography (OCT) imaging and visual acuity tests.
This study is focused on improving the understanding of bromfenac's role in postoperative eye care and helping optimize treatment protocols for cataract surgery patients to ensure better outcomes and prevent vision-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromfenac Group | Experimental | Drug: Bromfenac, Drug: Moxifloxacin 0.5% ophthalmic solution, Drug: Dexamethasone phosphate 0.1%Participants in this group will receive bromfenac 0.09% ophthalmic solution as part of their postoperative care regimen following cataract surgery. • Interventions: 0.09% bromfenac ophthalmic solution twice daily in addition to Moxifloxacin 0.5% ophthalmic drops every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs for six weeks |
| Control Group | Active comparator | Drug: Moxifloxacin 0.5% ophthalmic solution, Drug: Dexamethasone phosphate 0.1%: Participants in this group will receive the standard postoperative care regimen without bromfenac. • Interventions: Moxifloxacin 0.5% every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs for six weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients 18 years of age and older.
- Patients diagnosed with cataracts.
Key exclusion criteria (17 listed)
- Patients less than 18 years of age.
- Patients with glaucoma, ocular hypertension, pseudo-exfoliation syndrome, or any optic nerve disease.
- Patients with ocular diseases that might influence macular thickness, such as:
- Age-related macular degeneration
- Epiretinal membrane
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 |
|---|---|---|
| BromfenacBromfenac is a non-steroidal anti-inflammatory drug (NSAID) formulated as a 0.09% ophthalmic solution. It is administered to reduce inflammation and prevent cystoid macular edema (CME) following cataract surgery. | Drug | Bromfenac Group |
| Moxifloxacin 0.5% ophthalmic solutionantibiotic, standard postoperative care regimen | Drug | Bromfenac Group, Control Group |
| Dexamethasone phosphate 0.1%steroid, standard postoperative care regimen | Drug | Bromfenac Group, Control Group |
Primary outcome
Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery
Time frame: 6 weeks postoperatively
This outcome measures the change in macular thickness in participants treated with bromfenac ophthalmic solution compared to the control group. Macular thickness was assessed using Optical Coherence Tomography (OCT) at two time points: preoperatively (baseline) and 6 weeks postoperatively. The change was calculated as: Macular Thickness at 6 Weeks Postoperative - Baseline Macular Thickness. A negative value indicates a decrease (thinning), while a positive value indicates an increase (thickening) in macular thickness.
1 secondary outcome
Incidence of Adverse Events Related to Bromfenac
Time frame: 6 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- This link provides access to the de-identified raw data from the clinical trial investigating the effects of bromfenac on macular thickness in cataract patients following phacoemulsification surgery.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this time, the plan to share individual participant data (IPD) is undecided. While the raw data from this study has been deposited in the public repository Zenodo to ensure accessibility, further decisions on sharing additional data or providing access to specific datasets will depend on future collaborations, publication requirements, and institutional guidelines.
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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.
Zaid R Hussein, consultant ophthalmologist study director
Ibn Al Haitham eye teaching hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bromfenac, Moxifloxacin 0.5% ophthalmic solution and Dexamethasone phosphate 0.1% in people with Cataract and Cystoid Macular Edema After Phacoemulsification, run by Inas Abd at 1 site in Iraq.
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 2 inclusion and 17 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 6 May 2025. 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 Iraq. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery (time frame: 6 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.