Comparison Between Low-Dose and High-Dose Nepafenac Sodium

NCT07749027 | Completed

• 1 other identifier: Dr-Zulfiqar-QAMC
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract; macular edema; nepafenac; sodium; topical

Outcome Measures

Primary Outcomes (1)

• Central macular thickness

  Reduction in the mean central macular thickness was compared with the baseline to postoperative day 60.

  60 days after surgery

Secondary Outcomes (2)

• Macular edema index

  60 days after surgery

• Treatment compliance

  60 days after surgery

Study Arms (2)

High-dose nepafenac sodium

EXPERIMENTAL

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.

Drug: Nepafenac sodium (High-dose )

Low-dose nepafenac sodium

EXPERIMENTAL

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.

Drug: Nepafenac sodium (Low-dose )

Interventions

Nepafenac sodium (High-dose ) DRUG

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.

High-dose nepafenac sodium

Nepafenac sodium (Low-dose ) DRUG

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.

Low-dose nepafenac sodium

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Any gender
• Aged 18-60 years
• Planned for cataract surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Bahawal Victoria Hospital/Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Cataract; Macular Edema

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Study Officials

• Zulfiqar Ali, FCPS

  Bahawal Victoria Hospital/Quaid-e-Azam Medical College

  PRINCIPAL INVESTIGATOR

• Soufia Farrukh, FCPS

  Bahawal Victoria Hospital/Quaid-e-Azam Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking involved
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Model Details: 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

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start: January 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)