Efficacy of steroid and nonsteroidal anti-inflammatory eye drops after uncomplicated cataract surgery

Efficacy of steroid and nonsteroidal anti-inflammatory eye drops in management of post-operative inflammation and prevention of pseudophakic cystic macular edema after uncomplicated cataract surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003296-30-FI

Enrollment

300

Registered

2015-07-29

Start date

2015-11-11

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Cataract senilis

Interventions

Trade Name: Nevanac Product Name: NEVANAC Pharmaceutical Form: Eye drops, suspension INN or Proposed INN: NEPAFENAC Other descriptive name: NEPAFENAC Concentration unit: mg/ml milligram(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 60-90 years Fulfills national criteria for cataract surgery (Kaihi – Käypä Hoito -suositus 2013) 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260

Exclusion criteria

Exclusion criteria: No active wet AMD No planned anti-VEGF therapy No prior retinal artery or vein occlusion No prior retinal detachment No prior makular grid-laserphotocoagulation No prior optic neuritis No prior vitreous hemorrhage No myopia magna No prior intraocular surgery No pregnancy No alcohol misuse

Design outcomes

Primary

Measure	Time frame
Main Objective: To study efficacy of steroid and nonsteroidal anti-inflammatory eye drops in management of post-operative inflammation and prevention of pseudophakic cystic macular edema after uncomplicated cataract surgery;Secondary Objective: To study efficacy of steroid and nonsteroidal anti-inflammatory eye drops in prevention of posterior capsule opacification after uncomplicated cataract surgery;Primary end point(s): Best corrected visual acuity, intraocular pressure, central retinal thickness, aqueous flare ;Timepoint(s) of evaluation of this end point: 1 month	—

Measure

Time frame

Main Objective: To study efficacy of steroid and nonsteroidal anti-inflammatory eye drops in management of post-operative inflammation and prevention of pseudophakic cystic macular edema after uncomplicated cataract surgery;Secondary Objective: To study efficacy of steroid and nonsteroidal anti-inflammatory eye drops in prevention of posterior capsule opacification after uncomplicated cataract surgery;Primary end point(s): Best corrected visual acuity, intraocular pressure, central retinal thickness, aqueous flare ;Timepoint(s) of evaluation of this end point: 1 month

—

Secondary

Measure	Time frame
Secondary end point(s): Amount of posterior capsule opacification;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Finland

Contacts

Public ContactClinical Trials Information

Raimo Tuuminen

raimo.tuuminen@helsinki.fi

Outcome results

None listed

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