Cataract, Cystoid Macular Edema After Phacoemulsification
Conditions
Keywords
cataract, phacoemulsification, cystoid macular edema
Brief 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. 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.
Interventions
antibiotic, standard postoperative care regimen
DRUGBromfenac
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.
DRUGDexamethasone phosphate 0.1%
steroid, standard postoperative care regimen
Sponsors
Inas Abd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients 18 years of age and older. * Patients diagnosed with cataracts.
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events Related to Bromfenac | 6 weeks postoperatively | 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 |
Countries
Iraq
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 42 |
| Total | 87 |
Baseline characteristics
| Characteristic | Bromfenac Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 44 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 43 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 87 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Preoperative Macular Thickness | 252.6 Microns STANDARD_DEVIATION 15.4 | 252.8 Microns STANDARD_DEVIATION 15.1 | 253.1 Microns STANDARD_DEVIATION 14.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 45 Participants | 87 Participants | 42 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Male | 25 Participants | 45 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 42 |
| other Total, other adverse events | 5 / 45 | 0 / 42 |
| serious Total, serious adverse events | 0 / 45 | 0 / 42 |
Outcome results
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.
Time frame: 6 weeks postoperatively
Population: All participants were included in the analysis, with no exclusions due to missing data, dropouts, or protocol violations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bromfenac Group | Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery | 252.6 Microns | Standard Deviation 15.4 |
| Control Group | Change in Macular Thickness From Baseline to 6 Weeks Postoperatively After Cataract Surgery | 253.1 Microns | Standard Deviation 14.8 |
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
Time frame: 6 weeks postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bromfenac Group | Incidence of Adverse Events Related to Bromfenac | 5 Participants |