Título / Title

EFFECT OF DEXAMETHASONE ON REDUCTION OF MACULAR THICKNESS IN DIABETIC PATIENTS, A RANDOMIZED CLINICAL TRIAL

Introdução / Purpose

To determine the impact of short-term 4mg/ml dexamethasone solution treatment in diabetic macular edema (DME).

Material e Método / Methods

Methods: Twenty-seven patients with visual impairment caused by DME were randomized in a 1:1:1 ratio, in order to investigate treatment with 0.01 ml, 0.03 ml and 0.05 ml intravitreous dexamethasone solutions, and followed-up over 28 days.
Participants: Pseudophakic patients with central-involved DME.

Resultados / Results

There was a significant reduction in macular thickness between D0 and D3 for all groups (0.01ml – p = 0.008; 0.03 ml – p = 0.038; and 0.05 ml – p = 0.008). Between D0 and D28, no significant reduction of macular thickness was observed for all groups (0.01 ml – p = 0.678; 0.03 ml – p = 0.953; and 0.05 ml – p = 0.859). Between D0 and D3, a significant improvement in BCVA in the 0.03 ml group (p = 0.028) was observed, while no significant improvement was seen in the other groups (0.01 ml – p = 0.077 and 0.05 ml – p = 0.600). Between D0 and D28, a significant improvement in BCVA was observed for the 0.01 ml group (p = 0.017), while no significant improvement was observed in the other groups (0.03 ml – p = 0.249, and 0.05 ml – p = 0.260). Between D0 and D3, no significant differences in IOP measurements were observed for any group (0.01 ml – p = 0.887; 0.03 ml – p = 0.773 and 0.05 ml – p = 0.348). The same occurred between D0 and D28 for all groups (0.01 ml – p = 0.414, 0,03 ml – p =0 .107 and 0.05 ml – p =0.488). Safety analysis revealed no serious ocular or systemic events during the study, with no reports of endophthalmitis, or retinal detachment.

Discussão e Conclusões / Conclusion

Intravitreous dexamethasone solution is effective in reducing diabetic macular edema in the short-term, with no evidence to suggest that it may cause a permanent increase in intraocular pressure. Improvement in short-term visual acuity was observed.

Palavras Chave

dexamethasone solution, diabetic macular edema; pseudophakic patients, macular thickness reduction.