Treatment of Cystoid Macular Edema following cataract surgery. A randomized, double-masked, placebo-controlled, clinical trial. - Treatment of post-cataract CME

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017031-18-NL

Enrollment

120

Registered

2009-11-26

Start date

2010-04-09

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cystoid macular edema

Interventions

Product Name: nepafenac Product Code: nepafenac Pharmaceutical Form: Eye drops* Pharmaceutical form of the placebo: Eye drops* Route of administration of the placebo: Ocular use Product Name: presnis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosed or suspect clinical CME within three months after phacoemulsification - CME on OCT Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Diabetes mellitus I/II - Corneal complications - Age related macula degeneration (wet and dry) - History of steroid response (IOP-rise) - Hypersensitivity to NSAIDs / NSAID-induced asthma - Use of systemic steroid medication / NSAIDs - Rheumatoid arthritis

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the efficacy of treatment with Nevanac in combination with Pred Forte of acute clinical inflammation resulting in Cystoid Macular Edema after phacoemulsification. ;Secondary Objective: NA;Primary end point(s): At 12 weeks: - OCT-proven CME (yes/no) - Best corrected visual acuity as determined by ETDRS	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026