on-steroidal anti-inflammatory (NSAID) medication in cataract surgery

Phase 1

Conditions: Cataract senilis
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2015-005313-79-FI

Lead Sponsor: Raimo Tuuminen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study efficacy different nonsteroidal anti-inflammatory eye drops in management of post-operative inflammation and prevention of pseudophakic cystic macular edema after uncompplicated cataract surgery;Secondary Objective: To study efficacy different nonsteroidal anti-inflammatory eye drops in prevention of posterior capsule opacification after uncompplicated 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 Outcome Measures

Name	Time	Method
Secondary end point(s): Best corrected visual acuity, intraocular pressure, central retinal thickness, aqueous flare;Timepoint(s) of evaluation of this end point: 3 month