Pseudophakic Cystoid Macular EdemaPhase 4NCT07696104
Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification
A Phase 4 study testing Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.1% eyedrops and diclofenac 0.1% ophthalmic susp. in people with Pseudophakic Cystoid Macular Edema, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pseudophakic Cystoid Macular Edema
- What is being tested?
- Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.1% eyedrops and diclofenac 0.1% ophthalmic susp.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePoland
- Study dates
- 14 Oct 2020to 22 May 2024
- Phase
- Phase 4
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
- Ability and willingness to provide written informed consent.
- No abnormalities detected on preoperative anterior segment examination.
- No abnormalities detected on preoperative posterior segment examination.
- Willingness and ability to attend follow-up visits at 6 and 12 weeks after cataract surgery.
Who cannot join
- The exclusion criteria for the study were:
- Systemic diseases that could affect the macula (e.g. diabetes).
- Topical or systemic medications that could affect the macula, e.g. chloroquine.
- Intraoperative complications.
- Coexisting ocular diseases.
- Previous ocular surgery.
- Patients who. for various reasons. declared unwillingness to attend follow-up visits 6 and 12 weeks after cataract surgery.
Trial locations and contacts
1 site in 1 country.
Poland1 site
University Clinical Hospital No. 2, Pomeranian Medical University in Szczecin
Szczecin, 70-111
About this study
This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks. All patients received the same standard perioperative care and adjunctive dexamethasone treatment. The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery. Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.
Read the detailed description
Cystoid macular edema remains one of the most important causes of suboptimal visual outcomes after cataract surgery. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce postoperative inflammation and the risk of macular thickening; however, the optimal NSAID regimen remains uncertain.
This prospective randomized clinical study was designed to compare the effectiveness of different postoperative NSAID regimens following uncomplicated phacoemulsification cataract surgery. Eligible patients scheduled for elective cataract surgery were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure. Participants underwent ophthalmic examinations before surgery and at 6 and 12 weeks after surgery.
The primary objective was to evaluate changes in central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT). Secondary assessments included best-corrected distance visual acuity, refraction, and intraocular pressure. All participants received standard perioperative care, and postoperative treatment was administered according to the assigned study regimen.
The study was approved by the Bioethics Committee of the Pomeranian Medical University in Szczecin, and all participants provided written informed consent before enrollment.
- Conditions
- Pseudophakic Cystoid Macular Edema
- Being tested
- Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.1% eyedrops, diclofenac 0.1% ophthalmic susp.
- Keywords
- cataract, NSAID, PCME
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac 0.09 % Ophthalmic SolutionDrug
Bromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery.
Bromfenac 0.09 % Ophthalmic SolutionDrug
Bromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery.
Nepafenac 0.1% eyedropsDrug
Nepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery.
diclofenac 0.1% ophthalmic susp.Drug
Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Bromfenac 0.09% for 2 Weeks | Experimental | Arm 1 - Bromfenac 0.09% for 2 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 2 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. Receives: Drug: Bromfenac 0.09 % Ophthalmic Solution |
| Arm 2 Bromfenac 0.09% for 4 Weeks | Experimental | Arm 2 - Bromfenac 0.09% for 4 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. Receives: Drug: Bromfenac 0.09 % Ophthalmic Solution |
| Arm 3 - Diclofenac 0.1% for 4 Weeks | Experimental | Arm 3 - Diclofenac 0.1% for 4 Weeks Participants received diclofenac 0.1% ophthalmic solution four times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. Receives: Drug: diclofenac 0.1% ophthalmic susp. |
| Arm 4 - Nepafenac 0.1% for 4 Weeks | Experimental | Arm 4 - Nepafenac 0.1% for 4 Weeks Participants received nepafenac 0.1% ophthalmic solution three times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. Receives: Drug: Nepafenac 0.1% eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Central Subfield Thickness After Cataract Surgery
Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), to compare postoperative macular thickness among treatment groups receiving different topical nonsteroidal anti-inflammatory drug (NSAID) regimens following uncomplicated cataract surgery.
Measured: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery
Secondary outcomes (3)
Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity
Correlation between central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), and distance best-corrected visual acuity (DBCVA), reported as decimal visual acuity, measured using a Snellen chart, at 6 and 12 weeks after uncomplicated cataract surgery.
Measured: 6 weeks and 12 weeks after cataract surgery compare to baseline
Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group
Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), compared between eyes with postoperative distance best-corrected visual acuity (DBCVA) <0.9 and eyes with postoperative DBCVA of 0.9-1.0, measured using a Snellen chart and reported as decimal visual acuity, at 6 and 12 weeks after uncomplicated cataract surgery.
Measured: 6 weeks and 12 weeks after cataract surgery
Change in Central Subfield Thickness From Baseline
Change in central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), from baseline (preoperative assessment) to 6 and 12 weeks after uncomplicated cataract surgery in all study participants, regardless of the assigned topical nonsteroidal anti-inflammatory drug (NSAID) regimen.
Measured: Baseline, 6 weeks, and 12 weeks after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start14 Oct 2020
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudophakic Cystoid Macular EdemaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of four parallel treatment groups using a simple dice-based randomization procedure. Each participant received only one study treatment regimen and was followed for 12 weeks after cataract surgery.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696104
- Sponsor's protocol ID
- MD-CATARACT-NSAID-2024
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the future sharing of individual participant data has not yet been made
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification
- ClinicalTrials.gov ID
- NCT07696104
- Acronym / sponsor ID
- MD-CATARACT-NSAID-2024
- Conditions
- Pseudophakic Cystoid Macular Edema
- Keywords
- cataract, NSAID, PCME
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 10 Jul 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.
This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks. All patients received the same standard perioperative care and adjunctive dexamethasone treatment. The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery. Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.
Detailed description
Cystoid macular edema remains one of the most important causes of suboptimal visual outcomes after cataract surgery. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce postoperative inflammation and the risk of macular thickening; however, the optimal NSAID regimen remains uncertain.
This prospective randomized clinical study was designed to compare the effectiveness of different postoperative NSAID regimens following uncomplicated phacoemulsification cataract surgery. Eligible patients scheduled for elective cataract surgery were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure. Participants underwent ophthalmic examinations before surgery and at 6 and 12 weeks after surgery.
The primary objective was to evaluate changes in central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT). Secondary assessments included best-corrected distance visual acuity, refraction, and intraocular pressure. All participants received standard perioperative care, and postoperative treatment was administered according to the assigned study regimen.
The study was approved by the Bioethics Committee of the Pomeranian Medical University in Szczecin, and all participants provided written informed consent before enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants were randomly assigned to one of four parallel treatment groups using a simple dice-based randomization procedure. Each participant received only one study treatment regimen and was followed for 12 weeks after cataract surgery.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Bromfenac 0.09% for 2 Weeks | Experimental | Drug: Bromfenac 0.09 % Ophthalmic SolutionArm 1 - Bromfenac 0.09% for 2 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 2 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. |
| Arm 2 Bromfenac 0.09% for 4 Weeks | Experimental | Drug: Bromfenac 0.09 % Ophthalmic SolutionArm 2 - Bromfenac 0.09% for 4 Weeks Participants received bromfenac 0.09% ophthalmic solution twice daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. |
| Arm 3 - Diclofenac 0.1% for 4 Weeks | Experimental | Drug: diclofenac 0.1% ophthalmic susp.Arm 3 - Diclofenac 0.1% for 4 Weeks Participants received diclofenac 0.1% ophthalmic solution four times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. |
| Arm 4 - Nepafenac 0.1% for 4 Weeks | Experimental | Drug: Nepafenac 0.1% eyedropsArm 4 - Nepafenac 0.1% for 4 Weeks Participants received nepafenac 0.1% ophthalmic solution three times daily for 4 weeks following uncomplicated phacoemulsification cataract surgery. All participants also received standard perioperative care and postoperative dexamethasone treatment. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
- Ability and willingness to provide written informed consent.
- No abnormalities detected on preoperative anterior segment examination.
- No abnormalities detected on preoperative posterior segment examination.
- Willingness and ability to attend follow-up visits at 6 and 12 weeks after cataract surgery.
Key exclusion criteria (7 listed)
- Systemic diseases that could affect the macula (e.g. diabetes).
- Topical or systemic medications that could affect the macula, e.g. chloroquine.
- Intraoperative complications.
- Coexisting ocular diseases.
- Previous ocular surgery.
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 |
|---|---|---|
| Bromfenac 0.09 % Ophthalmic SolutionBromfenac 0.09% ophthalmic solution administered twice daily for 2 weeks after cataract surgery. | Drug | Arm 1 Bromfenac 0.09% for 2 Weeks |
| Bromfenac 0.09 % Ophthalmic SolutionBromfenac 0.09% ophthalmic solution administered twice daily for 4 weeks after cataract surgery. | Drug | Arm 2 Bromfenac 0.09% for 4 Weeks |
| Nepafenac 0.1% eyedropsNepafenac 0.1% ophthalmic solution administered three times daily for 4 weeks after cataract surgery. | Drug | Arm 4 - Nepafenac 0.1% for 4 Weeks |
| diclofenac 0.1% ophthalmic susp.Diclofenac 0.1% ophthalmic solution administered four times daily for 4 weeks after cataract surgery. | Drug | Arm 3 - Diclofenac 0.1% for 4 Weeks |
Primary outcome
Changes in Central Subfield Thickness After Cataract Surgery
Time frame: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery
Central subfield thickness (CST), reported in micrometers (µm), measured by spectral-domain optical coherence tomography (Cirrus HD-OCT 5000, Carl Zeiss), to compare postoperative macular thickness among treatment groups receiving different topical nonsteroidal anti-inflammatory drug (NSAID) regimens following uncomplicated cataract surgery.
3 secondary outcomes
Correlation Between Central Subfield Thickness and Distance Best-Corrected Visual Acuity
Time frame: 6 weeks and 12 weeks after cataract surgery compare to baseline
Central Subfield Thickness by Postoperative Distance Best-Corrected Visual Acuity Group
Time frame: 6 weeks and 12 weeks after cataract surgery
Change in Central Subfield Thickness From Baseline
Time frame: Baseline, 6 weeks, and 12 weeks after cataract 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 10 Jul 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the future sharing of individual participant data has not yet been made
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.1% eyedrops and diclofenac 0.1% ophthalmic susp. in people with Pseudophakic Cystoid Macular Edema, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 5 inclusion and 7 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 10 Jul 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in Central Subfield Thickness After Cataract Surgery (time frame: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract 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 10 Jul 2026.