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.
- Conditions
- Post-cataract extraction ocular inflammation.
- Registration Number
- EUCTR2006-001486-41-NL
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of incidence of post-cataract extraction ocular inflammation with subconjunctival steroid injection versus traditional eye drops.<br>;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.<br>Thickness of the macula, examined by OCT, before operation and on day 21. <br>
- Secondary Outcome Measures
Name Time Method