研究目的
To examine the efficacy of intravitreal aflibercept and navigated laser as compared to intravitreal aflibercept and conventional laser in diabetic macular oedema (DME) treatment.
研究成果
No differences were demonstrated in regard to need for retreatment or functional outcome between treatment arms of aflibercept and navigated vs. conventional focal/grid laser photocoagulation in DME. The study demonstrated a good functional outcome with a remarkably low need for intravitreal aflibercept in patients with centre-involved DME.
研究不足
The study was limited by the number of participants and the lack of a control group treated with aflibercept alone. A longer follow-up period could potentially have increased the chance of finding true statistical differences between groups.
1：Experimental Design and Method Selection:
A 12-month randomized clinical trial comparing intravitreal aflibercept and navigated laser versus intravitreal aflibercept and conventional laser in DME treatment.
2：Sample Selection and Data Sources:
48 eyes of 37 patients with centre-involved DME at Odense University Hospital.
3：List of Experimental Equipment and Materials:
Navilas laser system, PASCAL laser system, optical coherence tomography (OCT) by 3D OCT-2000 Spectral domain OCT, fundus fluorescein angiography (FFA) with TRC-50DX fundus camera.
4：Experimental Procedures and Operational Workflow:
Patients received three monthly injections of aflibercept followed by navigated or conventional focal/grid laser. Monthly examinations from month four through twelve with additional injections as needed.
5：Data Analysis Methods:
Statistical analysis performed using STATA version 15.1, employing cluster robust standard errors for linear regression models.
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