Effects of post-operative topical steroid versus intraoperative subconjunctival steroid injection and postoperative miotic on intraocular inflammation following cataract extraction.
Phase 4
Completed
- Conditions
- inflammation of the eye after cataract surgery10021877
- Registration Number
- NL-OMON34332
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
Cataract extraction indication.
Age > 18 years.
Caucasian.
Informed consent.
Post-op follow-up must be feasible.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Laser flarecount, examined by laser flarecounter, before operation and on day<br /><br>21.<br /><br>Thickness of the macula, examined by OCT, before operation and on day 21. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Intraocular pressure on day 1 and 21.<br /><br>Phaco time and energy.<br /><br>Number of extra visits due to complaints of post-op irritation.<br /><br>Number of extra visits due to complaints of reduced visual acuity.<br /><br>Pain (scaling 1-10) on day 1.<br /><br>Incidence of anterior synechiae on day 21.<br /><br>BCVA on day 21.</p><br>