Timing of anti-inflammatory combination therapy in diabetic cataract surgery

Pre and post-operative corticosteroid and NSAID combination treatment in cataract surgery of diabetic patient

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004514-10-FI

Enrollment

104

Registered

2016-11-30

Start date

2017-03-08

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: Oftan Dexa 1mg/ml Product Name: Oftan Dexa 1mg/ml Pharmaceutical Form: Eye drops, solution Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE Trade Name: Nevanac 1mg/ml Product Name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 60-90 years Fullfills national criteria for cataract surgery 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

Exclusion criteria: active wet AMD /planned anti-VEGF therapy prior retinal vein/artery occlusiion, retinal detachment, optic neuritis, vitreous hemorrhage, intraocular surgery. Myopia magna. Pregnancy. Alcohol misuse.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study efficacy of pre- and post-operative corticosteroid and nonsteroidal anti-inflammatory drug therapy in management of post-operative inflammation and prevention of pseudophakic cystic macular edema after uncomplicated cataract surgery in diabetic patients;Secondary Objective: To study pre- and post-operative corticosteroid and nonsteroidal anti-inflammatory drug therapy on perioperative discomfort and recovery from uncomplicated cataract surgery in diabetic patients;Primary end point(s): Best corrected visual acuity, intraocular pressure, central retinal thickness, aqueous flare;Timepoint(s) of evaluation of this end point: 1 and 3 months	—

Measure

Time frame

Main Objective: To study efficacy of pre- and post-operative corticosteroid and nonsteroidal anti-inflammatory drug therapy in management of post-operative inflammation and prevention of pseudophakic cystic macular edema after uncomplicated cataract surgery in diabetic patients;Secondary Objective: To study pre- and post-operative corticosteroid and nonsteroidal anti-inflammatory drug therapy on perioperative discomfort and recovery from uncomplicated cataract surgery in diabetic patients;Primary end point(s): Best corrected visual acuity, intraocular pressure, central retinal thickness, aqueous flare;Timepoint(s) of evaluation of this end point: 1 and 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): Perioperative discomfort and recovery from surgery;Timepoint(s) of evaluation of this end point: The day of operation and the first postoperative days	—

Countries

Finland

Contacts

Public ContactClinical Trials Information

Raimo Tuuminen

raimo.tuuminen@helsinki.fi358504113870

Outcome results

None listed

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