Refractory diabetic macular edema
Conditions
Interventions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Aged 18 years or older; 2. Recurrent or refractory clinically significant macular edema (CSME), after previous treatment(s), as defined according to the ETDRS; 3. Macular edema of at least 250µm involving the fovea, as documented on optical coherent tomogram; 4. Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart); 5. Patients physically fit to receive treatment and comply with follow-up schedule; 6. Informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error; 2. Proliferative diabetic retinopathy; 3. Media opacities which affect fundus examination or OCT measurements; 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion more than 6 months prior to enrollment; 5. Ocular laser procedure within 4 months; 6. History of fluorescein allergy; 7. Fellow eye visual acuity worse than 20/400
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Best-corrected visual acuity;2. Central foveal thickness as measured by optical coherent tomogram;3. Proportion of patients with a) moderate visual loss or b) stable/ gain in visionnn; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intraocular pressure;2. Changes in fluorescein angiography;3. Adverse events; | — |