Topical dexamethasone -cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema

• PurposeTo compare in a randomized, controlled trial topical 1.5% dexamethasone -cyclodextrin nanoparticle eye drops (DexNP) with posterior subtenon injection of triamcinolone acetonide in diabetic macular oedema (DME). MethodsIn this prospective, randomized, controlled trial, 22 eyes of 22 consecutive patients with DME were randomized to (i) topical treatment with DexNP x3/day (4weeks), x2/day (4weeks) and x1/day (4weeks) or (ii) one posterior subtenon injection of 20mg triamcinolone acetonide. Study visits were at baseline and 4, 8, 12 and 16weeks. ResultsThe logMAR (Snellen) visual acuity (meanSD) improved significantly with DexNP from 0.41 +/- 0.3 (Snellen 0.39) to 0.32 +/- 0.25 (0.48) and 0.30 +/- 0.26 (0.50) at 4 and 8weeks, respectively. One-third of the DexNP group improved more than 0.3 logMAR units. For triamcinolone, logMAR changed significantly from 0.42 +/- 0.28 (0.38) at baseline to 0.32 +/- 0.29 (0.48) at 4w and 0.33 +/- 0.37 (0.47) at 12w. The central macular thickness (CMT) decreased significantly with DexNP from 483 +/- 141m to 384 +/- 142m at 4w and 342 +/- 114m at 8w. For triamcinolone, CMT decreased significantly at all time-points: 494 +/- 94m, 388 +/- 120, 388 +/- 145, 390 +/- 136 and 411 +/- 104m at 0, 4, 8, 12 and 16weeks, respectively. There was a modest increase in intraocular pressure (IOP) at all time-points with DexNP while no increase was seen with triamcinolone. Serum cortisol was affected by both treatments. ConclusionTopical DexNP significantly improve visual acuity and decrease macular thickness in patients with DME. The effect is similar to that from subtenon triamcinolone. A modest increase in IOP was seen with the nanoparticle eye drops, but IOP normalized after the discontinuation of treatment.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Oftalmologi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Ophthalmology (hsv//eng)

Nyckelord

cyclodextrin

dexamethasone

diabetes macular edema

nanoparticle

topical treatment

iamcinolone

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