Skip to main content
OpenTrials
Completed

NCT Number: NCT07749027

Comparison Between Low-Dose and High-Dose Nepafenac Sodium

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahawal Victoria Hospital/Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Central macular thickness

    Time frame: 60 days after surgery

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

Secondary outcomes

  1. Macular edema index

    Time frame: 60 days after surgery

    Reduction in the macular edema index was compared to the baseline.

  2. Treatment compliance

    Time frame: 60 days after surgery

    Frequencies of patients who completed the treatment successfully were compared between two groups.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Comparison Between Low-dose and High-dose Nepafenac Sodium in Preventing Macular Edema After Cataract Surgery.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.