The purpose of this study is to evaluate the safety end efficacy of combined phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use of bevacizumab in patients with diffuse diabetic macular edema (DDME), to determine the possible preoperative and intraoperative factors that might influence surgical outcomes.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. diagnosis of DDME on clinical exam, definite retinal thickening involving the center of the macula, confirmed by fluorescein angiography, with or without PVD,
✓. BCVA of 0,3 or worse in log MAR units (\<=70 ETDRS letter) and 1,5 or better in log MAR units (\>=10 ETRDS letter),
✓. mean central macular thickness greater than 250 μm on optic coherence tomography (OCT),
✓. presence of vitreomacular traction or a thickened and taut posterior hyaloid or presence of an epimacular membrane.
Exclusion criteria
✕. significant macular ischemia defined as enlarged perifoveal capillary loss (\>1000 µm) by fluorescein angiography,
✕. the focal macular edema due to focal leakage from microaneurysm,
✕. ophthalmic disorders associated with macular edema, such as uveitis, branch or central retinal vein occlusion and pseudophakic cystoid macular edema,
✕. vitreous hemorrhage or tractional retinal detachment secondary to diabetic retinopathy,
✕. an ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, dense subfoveal hard exudates),
✕. history of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3 months prior to enrollment,
✕
What they're measuring
1
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: up to 1 week before surgery
2
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 16 up to 17 weeks after surgery
3
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 32 up to 33 weeks after surgery
4
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 48 up to 49 weeks after surgery
5
Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Timeframe: 64 up to 65 weeks after surgery
Trial details
NCT IDNCT01218750
SponsorMilitary Institute od Medicine National Research Institute