Intraocular pressure in patients with diabetic macular edema treated with dexamethasone intravitreal implant in the 3-year mead study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F16%3AN0000190" target="_blank" >RIV/00064173:_____/16:N0000190 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1097/IAE.0000000000001004" target="_blank" >http://dx.doi.org/10.1097/IAE.0000000000001004</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1097/IAE.0000000000001004" target="_blank" >10.1097/IAE.0000000000001004</a>
Alternative languages
Result language
angličtina
Original language name
Intraocular pressure in patients with diabetic macular edema treated with dexamethasone intravitreal implant in the 3-year mead study
Original language description
Purpose: To evaluate the occurrence, management, and clinical significance of increases in intraocular pressure (IOP) in patients with diabetic macular edema treated with dexamethasone intravitreal implant (DEX implant). Methods: Randomized, multicenter, 3-year, Phase III study. Patients (N = 1,048) with diabetic macular edema were randomized to DEX implant 0.7-mg, DEX implant 0.35-mg, or sham procedure with retreatment allowed at >= 6-month intervals (seven injections maximum). Results: In the DEX implant 0.7-mg, DEX implant 0.35-mg, and sham groups, respectively, >= 10-mmHg IOP increases from baseline occurred in 27.7%, 24.8%, and 3.7% of patients, and their frequency did not increase with repeat injections. IOP-lowering medication was used by 41.5%, 37.6%, and 9.1% of patients. Only one patient (0.3%) in each DEX implant group had filtering surgery to manage a steroid-induced IOP increase. Among DEX implant 0.7-mg-treated patients with and without a >= 10-mmHg IOP increase, 21.9% (21 of 96) and 22.4% (57 of 255), respectively, achieved >= 15-letter best-corrected visual acuity gain at the end of the study, and mean average change in central retinal thickness from baseline was -127 mm and -106 mm, respectively. Conclusion: DEX implant demonstrated clear benefit of treatment despite increases in IOP. Sequential implants had no cumulative effect on IOP.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FF - ENT (ie. ear, nose, throat), ophthalmology, dentistry
OECD FORD branch
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Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Retina
ISSN
0275-004X
e-ISSN
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Volume of the periodical
36
Issue of the periodical within the volume
6
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
1143-1152
UT code for WoS article
000377139100028
EID of the result in the Scopus database
2-s2.0-84957927695