Cystoid Macular Edema (CME) after phacoemulsification.
Conditions
Interventions
1. Group 1: Placebo eyedrops in two separate phials
2. Group 2: 6 weeks treatment of nepafenac 0,1% eye drops 3 times a day (d.d.), plus prednisolone acetate 1% eye drops 3 d.d.
Sponsors
Het Oogziekenhuis Rotterdam
Postbus 70030
3000 LM Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed or suspect clinical CME within three months after phacoemulsification; 2. CME on OCT; 3. Age > 18 years; 4. Informed consent; 5. Patients must be able to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus I/II; 2. Corneal complications; 3. Age related macula degeneration (wet and dry); 4. History of retinal detachment; 5. History of vitrectomy; 6. Macular disease; 7. History of steroid response (IOP-rise); 8. Hypersensitivity to NSAIDs / NSAID-induced asthma; 9. Use of systemic steroid medication / NSAIDs; 10. Pregnancy; 11. M. Addison / adrenal gland failure; 12. Chronic angle-closure glaucoma; 13. Complicated cataract operation; 14. Keratoconjunctivitis sicca; 15. Rheumatoid arthritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 12 weeks: 1. Optical Coherence Tomography (OCT)-proven CME (yes/no); 2. Best corrected visual acuity as determined by ETDRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OCT-proven CME (yes/no); 2. Clinical CME (yes/no) (i.e CME with reduced visual acuity of 2 or more lines); 3. Best corrected visual acuity as determined by ETDRS; 4. Thickness of the macula, examined by OCT RTVue (Optovue); 5. Active inflammation as measured by Laser flare count | — |
Contacts
Public ContactP.W.T. Waard, de
Oogziekenhuis Rotterdam Schiedamsevest 180
Outcome results
None listed