The post-cataract inflammatory reaction with combination therapy of topical steroid and NSAID. ble

The post-cataract inflammatory reaction with combination therapy of topical steroid and NSAID. - Post-cataract topical steroid & NSAID therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006066-40-NL

Enrollment

Registered

2011-12-23

Start date

2012-05-15

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

Ocular inflammatory reaction after cataract surgery.

Interventions

Trade Name: NEVANAC Pharmaceutical Form: Eye drops, suspension INN or Proposed INN: NEPAFENAC CAS Number: 78281-72-8 Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age > 18 years. - Caucasian. - Informed consent. - Post-op follow-up must be feasible. - Living at address with zip code of Rotterdam or close vicinity. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Subcapsular posterior cataract (very soft, short phaco time). - Brunescens or mature cataract (hard, long phaco time). - Diabetes mellitus. - Age-related macula degeneration. - History of uveitis. - Glaucoma. - History of steroid response. - Pre-operative synechiae anterior - Systemic or topical steroid medication. - Chemotherapy. - Sickle cell anemia. - Corneal complications. - Keratoconjunctivitis sicca - Rheumatoid arthritis - HSV.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the inflammatory reaction with NSAID and steroid prophylaxis.;Secondary Objective: None.;Primary end point(s): - Laser flare count (Kowa FM-600) - BCVA (ETDRS chart) ;Timepoint(s) of evaluation of this end point: Preop and postop days 1, 3, 5, 7, 10, 14, 21, 30, 60, 90.	—

Secondary

Measure	Time frame
Secondary end point(s): - Central macular thickness (OCT) - Corneal thickness - Intraocular pressure;Timepoint(s) of evaluation of this end point: Preop and postop days 1, 3, 5, 7, 10, 14, 21, 30, 60, 90.	—

Countries

Netherlands

Outcome results

None listed

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