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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaid R Hussein, consultant ophthalmologist | Ibn Al Haitham eye teaching hospital. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Medicine, University of Baghdad | Baghdad | Baghdad Governorate | 10001 | Iraq |
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| Label | URL |
|---|---|
| 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. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| inas.abd2206m@comed.uobaghdad. | Individual Participant Data Set | View IPD |
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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All participants underwent a pre-operative assessment, including eye exams, intraocular pressure measurements, visual acuity testing and a medical history review to screen for comorbidities. Eligible patients were randomized into two groups: Bromfenac treatment and control group.
Participants were recruited from the outpatient clinic at Jenna Ophthalmic Center. Eligible patients were adults aged 40-75 years with cataracts undergoing phacoemulsification surgery. Recruitment was done through clinic referrals and patient consultations. Patients were informed about the study and consent was obtained before enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bromfenac Group | This group received Bromfenac 0.09% ophthalmic solution, applied twice daily for 6 weeks following phacoemulsification surgery. The treatment was aimed at preventing cystoid macular edema (CME) and reducing macular thickness post-operatively. Participants were monitored for efficacy and any adverse events during the follow-up period. |
| FG001 | Control Group | This group received Moxifloxacin 0.5% ophthalmic drops every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6 hours post-operatively, without administering Bromfenac 0.09% ophthalmic drops. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline measures were reported for all participants enrolled in each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bromfenac Group | This group received Bromfenac 0.09% ophthalmic solution, applied twice daily for 6 weeks following phacoemulsification surgery. The treatment was aimed at preventing cystoid macular edema (CME) and reducing macular thickness post-operatively. Participants were monitored for efficacy and any adverse events during the follow-up period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | The number and percentage of male and female participants in each group were recorded at baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Posted | Count of Participants | Participants | 6 weeks postoperatively |
|
|
Adverse event data were collected over a 6-week postoperative period following cataract surgery.
Adverse events were defined as ocular complications during the 6-week postoperative period, including punctate epithelial erosion, ocular irritation, corneal edema, and intraocular pressure changes. Serious adverse events included significant visual impairment, infection, retinal detachment, or the need for surgery. Adverse events were assessed at follow-ups (1 day, 1 week, 6 weeks) through clinical exams, patient symptoms, and intraocular pressure measurements.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bromfenac Group | 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 Bromfenac: 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 solution: antibiotic, standard postoperative care regimen Dexamethasone phosphate 0.1%: steroid, standard postoperative care regimen |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate Epithelial Erosion (PEE) | Eye disorders | Systematic Assessment |
This study had a small sample size (45 in Bromfenac group, 42 in control), limiting statistical power. The short follow-up period of 6 weeks may not capture long-term effects. Results were based on a single-center study in Iraq, reducing generalizability. Adverse events were reported subjectively, which may have led to underreporting. Further studies with a larger sample size, extended follow-up, and diverse populations are needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enas Sabeeh | College of Medicine, University of Baghdad | 09647704294077 | inas.abd2206m@comed.uobaghdad.edu.iq |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2025 | Mar 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
| D000077266 | Moxifloxacin |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin 0.5% ophthalmic solution | Drug | antibiotic, standard postoperative care regimen |
|
| Dexamethasone phosphate 0.1% | Drug | steroid, standard postoperative care regimen |
|
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. |
| BG001 |
| Control Group |
This group received Moxifloxacin 0.5% ophthalmic drops every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6 hours post-operatively, without administering Bromfenac 0.09% ophthalmic drops. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Age, Categorical | Count of Participants | Participants |
|
| Preoperative Macular Thickness | Mean central macular thickness (CMT) in microns (µm) before surgery, measured using optical coherence tomography (OCT). | Mean | Standard Deviation | Microns |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | All participants were included in the analysis, with no exclusions due to missing data, dropouts, or protocol violations | Posted | Mean | Standard Deviation | Microns | 6 weeks postoperatively |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 5 |
| 45 |
| EG001 | Control Group | : 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 Moxifloxacin 0.5% ophthalmic solution: antibiotic, standard postoperative care regimen Dexamethasone phosphate 0.1%: steroid, standard postoperative care regimen | 0 | 42 | 0 | 42 | 0 | 42 |
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| D012164 |
| Retinal Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |