The effect of perioperative versus postoperative cortisone treatment in cataract surgery

Comparison between peri- and post-operative anti-inflammatory medication in cataract surgery: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004515-12-FI

Enrollment

100

Registered

2016-11-30

Start date

2017-03-31

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 INN or Proposed INN: DEXAMETHASONE Trade Name: Triesence 40mg/ml Product Name: Triesence 40mg/ml

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 80

Exclusion criteria

Exclusion criteria: glaucoma, ocular hypertony, cortisone responder active wet AMD /planned anti-VEGF therapy diabetes prior uveitis prior retinal vein/artery occlusion, retinal detachment, optic neuritis, vitreous hemorrhage, intraocular surgery. myopia magna. alcohol misuse.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare efficacy of post-operative topical dexamethasone administration and perioperative parabulbar triamsinolone delivery in management of post-operative inflammation after uncomplicated cataract surgery ;Secondary Objective: To compare efficacy of post-operative topical dexamethasone administration and perioperative parabulbar triamsinolone delivery in prevention of pseudophakic cystic macular edema after uncomplicated cataract surgery ;Primary end point(s): aqueous flare;Timepoint(s) of evaluation of this end point: 3, 7, 30 and 90 days	—

Measure

Time frame

Main Objective: To compare efficacy of post-operative topical dexamethasone administration and perioperative parabulbar triamsinolone delivery in management of post-operative inflammation after uncomplicated cataract surgery ;Secondary Objective: To compare efficacy of post-operative topical dexamethasone administration and perioperative parabulbar triamsinolone delivery in prevention of pseudophakic cystic macular edema after uncomplicated cataract surgery ;Primary end point(s): aqueous flare;Timepoint(s) of evaluation of this end point: 3, 7, 30 and 90 days

—

Secondary

Measure	Time frame
Secondary end point(s): Best corrected visual acuity, intraocular pressure and central retinal thichness ;Timepoint(s) of evaluation of this end point: 3, 7, 30 and 90 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