CataractNCT07749027
Comparison Between Low-Dose and High-Dose Nepafenac Sodium
A study testing Nepafenac sodium (High-dose ) and Nepafenac sodium (Low-dose ) in people with Cataract, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cataract
- What is being tested?
- Nepafenac sodium (High-dose ) and Nepafenac sodium (Low-dose )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Any gender
- Aged 18-60 years
- Planned for cataract surgery
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahawal Victoria Hospital/Quaid-e-Azam Medical College
Bahawalpur, Punjab Province, 63100
About this study
Official title: Comparison Between Low-dose and High-dose Nepafenac Sodium in Preventing Macular Edema After Cataract Surgery.
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- Nepafenac sodium (High-dose ), Nepafenac sodium (Low-dose )
- Keywords
- Cataract, macular edema, nepafenac, sodium, topical
- Medical subject headings
- Cataract, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nepafenac sodium (Low-dose ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickness
Reduction in the mean central macular thickness was compared with the baseline to postoperative day 60.
Measured: 60 days after surgery
Secondary outcomes (2)
Macular edema index
Reduction in the macular edema index was compared to the baseline.
Measured: 60 days after surgery
Treatment compliance
Frequencies of patients who completed the treatment successfully were compared between two groups.
Measured: 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Zulfiqar Ali, FCPS, Principal investigator, Bahawal Victoria Hospital/Quaid-e-Azam Medical CollegeSoufia Farrukh, FCPS, Study director, Bahawal Victoria Hospital/Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749027
- Sponsor's protocol ID
- Dr-Zulfiqar-QAMC
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Low-dose and High-dose Nepafenac Sodium in Preventing Macular Edema After Cataract Surgery.
- ClinicalTrials.gov ID
- NCT07749027
- Acronym / sponsor ID
- Dr-Zulfiqar-QAMC
- Conditions
- Cataract
- Keywords
- Cataract, macular edema, nepafenac, sodium, topical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| High-dose nepafenac sodium | Experimental | Drug: Nepafenac 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. |
| Low-dose nepafenac sodium | Experimental | Drug: Nepafenac 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Any gender
- Aged 18-60 years
- Planned for cataract surgery
Key exclusion criteria (17 listed)
- Patients with clinical or optical coherence tomography (OCT) evidence of pre-existing macular edema
- Uncontrolled hypertension
- Diabetes mellitus
- Previous stroke
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nepafenac 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. | Drug | High-dose nepafenac sodium |
| Nepafenac 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. | Drug | Low-dose nepafenac sodium |
Primary outcome
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.
2 secondary outcomes
Macular edema index
Time frame: 60 days after surgery
Treatment compliance
Time frame: 60 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar Ali, FCPS principal investigator
Bahawal Victoria Hospital/Quaid-e-Azam Medical College
Soufia Farrukh, FCPS study director
Bahawal Victoria Hospital/Quaid-e-Azam Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nepafenac sodium (High-dose ) and Nepafenac sodium (Low-dose ) in people with Cataract, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central macular thickness (time frame: 60 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.