Cataract
Conditions
Keywords
Cataract, macular edema, nepafenac, sodium, topical
Brief summary
In South Punjab, Pakistan, where tertiary hospitals manage a high cataract workload, data on nepafenac sodium to reduce this inflammatory response is not up to the mark. Relative benefit of low-dose versus high-dose regimens remains unclear in routine clinical practice. Therefore, this study was performed with the objective to compare the effectiveness of low-dose nepafenac sodium with high-dose nepafenac sodium in preventing macular edema after cataract surgery.
Detailed description
Cataract surgery is among the most commonly performed ophthalmic procedures but postoperative macular edema remains an important cause of delayed or suboptimal visual recovery because surgical inflammation can increase prostaglandin release, disrupt the blood-retinal barrier, and increase central macular thickness. Nepafenac sodium is used to reduce this inflammatory response yet the relative benefit of low-dose versus high-dose regimens remains unclear in routine clinical practice. Comparing low-dose with high-dose nepafenac sodium can therefore clarify whether a lower-dose regimen provides adequate protection with lower cost and treatment burden, or whether high-dose therapy offers superior anatomical and visual benefit after cataract surgery.
Interventions
DRUGNepafenac sodium (High-dose )
Patients received high-dose nepafenac sodium 0.3% ophthalmic suspension, one drop in the operated eye once daily, starting one day before cataract surgery, continued on the day of surgery, and then continued postoperatively until day 60. An additional drop was instilled 30-120 minutes before surgery.
DRUGNepafenac sodium (Low-dose )
Patients received low-dose nepafenac sodium 0.1% ophthalmic suspension, one drop in the operated eye three times daily, starting one day before cataract surgery, continued on the day of surgery, and then continued postoperatively until day 60. An additional preoperative drop was also instilled 30-120 minutes before surgery.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking involved
Intervention model description
Randomized was performed using a sealed opaque envelope method. Group-A received high-dose nepafenac sodium 0.3%, while Group-B received low-dose nepafenac sodium 0.1%, according to the assigned postoperative regimen. Group A received high-dose nepafenac sodium 0.3% ophthalmic suspension, one drop in the operated eye once daily, starting one day before cataract surgery, continued on the day of surgery, and then continued postoperatively until day 60. An additional drop was instilled 30-120 minutes before surgery. Group B received low-dose nepafenac sodium 0.1% ophthalmic suspension, one drop in the operated eye three times daily, starting one day before cataract surgery, continued on the day of surgery, and then continued postoperatively until day 60. An additional preoperative drop was also instilled 30-120 minutes before surgery. Patients in both groups received the same standard postoperative antibiotic and corticosteroid regimen according to departmental protocol, and no additional
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Any gender * Aged 18-60 years * Planned for cataract surgery
Exclusion criteria
* Patients with clinical or optical coherence tomography (OCT) evidence of pre-existing macular edema * Uncontrolled hypertension * Diabetes mellitus * Previous stroke * Renal failure * Ischemic heart disease with unstable symptoms * Acute or chronic uveitis * Retinitis pigmentosa * Diabetic retinopathy * Age-related macular degeneration * Epiretinal membrane * Retinal vein occlusion * Glaucoma * History of intraocular surgery * Traumatic cataract * Hypersensitivity to nepafenac or other non-steroidal anti-inflammatory drugs * Using topical or systemic anti-inflammatory drugs before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness | 60 days after surgery | Reduction in the mean central macular thickness was compared with the baseline to postoperative day 60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macular edema index | 60 days after surgery | Reduction in the macular edema index was compared to the baseline. |
| Treatment compliance | 60 days after surgery | Frequencies of patients who completed the treatment successfully were compared between two groups. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORZulfiqar Ali, FCPS
Bahawal Victoria Hospital/Quaid-e-Azam Medical College
STUDY_DIRECTORSoufia Farrukh, FCPS
Bahawal Victoria Hospital/Quaid-e-Azam Medical College
Outcome results
None listed