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Topical dexamethasone γ ‐cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema
Author(s) -
Ohira Akihiro,
Hara Katsunori,
Jóhannesson Gauti,
Tanito Masaki,
Ásgrímsdóttir Gudrún Marta,
Lund Sigrún H.,
Loftsson Thorsteinn,
Stefánsson Einar
Publication year - 2015
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/aos.12803
Subject(s) - triamcinolone acetonide , medicine , dexamethasone , visual acuity , ophthalmology , intraocular pressure , randomized controlled trial , corticosteroid , surgery
Purpose To compare in a randomized, controlled trial topical 1.5% dexamethasone γ ‐cyclodextrin nanoparticle eye drops (Dex NP ) with posterior subtenon injection of triamcinolone acetonide in diabetic macular oedema ( DME ). Methods In this prospective, randomized, controlled trial, 22 eyes of 22 consecutive patients with DME were randomized to (i) topical treatment with Dex NP ×3/day (4 weeks), ×2/day (4 weeks) and ×1/day (4 weeks) or (ii) one posterior subtenon injection of 20 mg triamcinolone acetonide. Study visits were at baseline and 4, 8, 12 and 16 weeks. Results The log MAR (Snellen) visual acuity (mean ± SD ) improved significantly with Dex NP 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 8 weeks, respectively. One‐third of the Dex NP group improved more than 0.3 log MAR units. For triamcinolone, log MAR 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 Dex NP from 483 ± 141 μm to 384 ± 142 μm at 4w and 342 ± 114 μm at 8w. For triamcinolone, CMT decreased significantly at all time‐points: 494 ± 94 μm, 388 ± 120, 388 ± 145, 390 ± 136 and 411 ± 104 μm at 0, 4, 8, 12 and 16 weeks, respectively. There was a modest increase in intraocular pressure ( IOP ) at all time‐points with Dex NP while no increase was seen with triamcinolone. Serum cortisol was affected by both treatments. Conclusion Topical Dex NP 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.