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Effects of post-operative topical steroid versus intraoperative subconjunctival steroid injection and postoperative miotic on intraocular inflammation following cataract extraction. - Subconjunctival steroid depot after cataract extraction.

Effects of post-operative topical steroid versus intraoperative subconjunctival steroid injection and postoperative miotic on intraocular inflammation following cataract extraction. - Subconjunctival steroid depot after cataract extraction.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001486-41-NL
Enrollment
400
Registered
2006-06-01
Start date
2006-09-19
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Post-cataract extraction ocular inflammation.

Interventions

Product Name: Celestone chronodose Product Code: RVG 05399 Pharmaceutical Form: Suspension for injection Product Name: Dexamethason ratiopharm 1 mgg/ml eye drops Product Code: RVG 56003 Pharmaceutica

Sponsors

Oogziekenhuis Rotterdam
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cataract extraction indication. Age > 18 years. Caucasian. Informed consent. Post-op follow-up must be feasible. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subcapsular posterior cataract (very soft, short phaco time). Brunescens or mature cataract (hard, long phaco time). Diabetes mellitus. Age-related macula degeneration. History of uveitis. Glaucoma. History of steroid response. Per-operative iris manipulation (e.g. miosis or posterior synechiae). Pre-operative synechiae anterior. Systemic steroid medication. Chemotherapy. Peroperative contact with vitreous. Sickle cell anemia. Corneal complications. Atopy. HSV.

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparison of incidence of post-cataract extraction ocular inflammation with subconjunctival steroid injection versus traditional eye drops. ;Secondary Objective: Evaluation of usefulness of physostigmine following cataract surgery.;Primary end point(s): Laser flarecount, examined by laser flarecounter, before operation and on day 21. Thickness of the macula, examined by OCT, before operation and on day 21.—

Countries

Netherlands

Outcome results

None listed

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