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Optimizing preoperative disinfection before ocular surgery

Optimizing preoperative disinfection before ocular surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2019-001179-35-NO
Enrollment
150
Registered
2019-08-06
Start date
2019-09-20
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial eye infections

Interventions

Trade Name: Minims Povidone Iodine 5% w/v Eye Drops, Solution Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Iodinated povidone Other descriptive name: POVIDONE, IODINATED PH. EUR. Conc

Sponsors

St. Olavs Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: referred to intravitreal injections, age 50 years or older, informed consent 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: Use of any eye drops or eye ointment the last 4 weeks. Any use of antibiotics og steroids the last 4 weeks. Active infection or inflammation in the eye or periorbital tissue. Diabetes mellitus type 1 or 2

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate which concentration of Povidone-Iodine (5% vs 0,3%) that most effectively reduces the conjunctival bacterial flora;Secondary Objective: To investigate any differences in experience/discomfort for the patients between Povidone-Iodine 5% and Povidone-Iodine 0,3%;Primary end point(s): Change in number of bacterial colonies before and after treatment with povidone-iodine;Timepoint(s) of evaluation of this end point: 1 day

Secondary

MeasureTime frame
Secondary end point(s): discomfort for the patient;Timepoint(s) of evaluation of this end point: 1 day

Countries

Norway

Contacts

Public ContactKlinikk for ØNH, Kjeve og øyesykdom

St Olavs Hospital

post.onh.kjeve.oye@stolav.no+47 72 575300

Outcome results

None listed

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