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Anti-inflammatory medication in cataract surgery of pseudoexfoliation eyes

Anti-inflammatory medication in cataract surgery of pseudoexfoliation eyes

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-004784-40-FI
Enrollment
150
Registered
2017-01-30
Start date
2017-03-03
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 1mg/ml Product Name: Nevanac 1mg/ml Product Code: S01GX09 Pharmaceutical Form: Ear drops, suspension Trade Name: Pred Forte 10mg/ml Product Name: Pred Forte 10mg/ml Pharmaceutical

Sponsors

Raimo Tuuminen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pseudoexfoliation 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To study efficacy of 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 pseudoexfoliation eyes;Secondary Objective: To study corticosteroid and nonsteroidal antiinflammatory drug therapy on perioperative discomfort and recovery from uncomplicated cataract surgery in pseudoexfoliation eyes;Primary end point(s): Best corrected visual acuity, central retinal thickness, aqueous flare;Timepoint(s) of evaluation of this end point: 1 and 3 months

Secondary

MeasureTime frame
Secondary end point(s): Intraocular pressure, postoperative discomfort and recovery from surgery;Timepoint(s) of evaluation of this end point: The first postoperative days and 3 months

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