Subconjunctival steroid depot after cataract extractio
Completed
- Conditions
- CataractEye DiseasesDisorders of lens
- Registration Number
- ISRCTN41133247
- Lead Sponsor
- The Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (OZR) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Cataract extraction indication
2. Aged over 18 years
3. Caucasian - informed consent
4. Post-op follow-up must be feasible
Exclusion Criteria
1. Subcapsular posterior cataract (very soft, short phaco time)
2. Brunescens or mature cataract (hard, long phaco time)
3. Diabetes mellitus
4. Age-related macula degeneration
5. History of uveitis
6. Glaucoma
7. History of steroid response
8. Per-operative iris manipulation (e.g. miosis or posterior synechiae)
9. Pre-operative synechiae anterior
10. Systemic steroid medication
11. Chemotherapy
12. Peroperative contact with vitreous
13. Sickle cell anemia
14. Corneal complications
15. Atopy
16. Herpes Simplex Virus (HSV)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Laser flarecount, examined by laser flarecounter, before operation and on day 21.<br>2. Thickness of the macula, examined by Optical Coherence Tomography (OCT), before operation and on day 21.
- Secondary Outcome Measures
Name Time Method 1. Number of extra visits due to complaints of post-op irritation.<br>2. Number of patients with macular edema, examined by OCT, on day 21. <br>3. Intraocular pressure on day one and 21.<br>4. Number of extra visits due to complaints of reduced visual acuity (miotic wearing off).<br>5. Pain (scaling one to ten) on day one.<br>6. Incidence of anterior synechiae (gonioscopic evaluation) on day 21.<br>7. Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart on day 21.