ID

12207

Descripción

Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema; ODM derived from: https://clinicaltrials.gov/show/NCT02399657

Link

https://clinicaltrials.gov/show/NCT02399657

Palabras clave

Versiones (1)
  1. 18/10/15 18/10/15 -
Subido en

18 de octubre de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT02399657

Inglés

Eligibility Diabetes Mellitus NCT02399657

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients diagnosed with csme (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center
Descripción

Clinically significant macular edema; hard soapy exudates of retina

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0730284
UMLS CUI [2]
C2029279
2. those who have a bcva (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)
Descripción

best corrected visual acuity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1690532
3. those who have a central macular thickness on oct over 300 micrometer
Descripción

Macular grid.center point thickness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2735398
4. if both eyes are eligible, eye having more hard exudates is selected (contralateral eye should be treated with corticosteroid other than ozurdex or focal laser photocoagulation, anti-vegf (vascular endothelial growth factor) injection is not allowed in contralateral eye)
Descripción

hard soapy exudates of retina

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2029279
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. those who have csme without hard exudates
Descripción

Clinically significant macular edema; Without; hard soapy exudates of retina

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0730284
UMLS CUI [2]
C0332288
UMLS CUI [3]
C2029279
2. those who have macular edema not related with diabetic retinopathy (e.g. amd (age-related macular degeneration), uveitis, retinal vein occlusion and untreated malignant hypertension)
Descripción

Macular retinal edema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0271051
3. those who have a history of intraocular surgery (e.g. cataract surgery) within 3 months
Descripción

surgery intraocular

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038894
UMLS CUI [1,2]
C3282905
4. those who have a visual acuity of contralateral eye less than 0.1 (10/100)
Descripción

visual acuity; eye

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042812
UMLS CUI [2]
C0015392
5. those who received focal laser treatment on macula within 3 months
Descripción

Laser treatment; Retinal macula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0850168
UMLS CUI [2]
C0450295
6. those who had intravitreal anti-vegf agent injection within 3 months
Descripción

Intravitreal Injections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1554888
7. those who had intravitreal triamcinolone injection within 6 months
Descripción

triamcinolone; Intravitreal Injections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040864
UMLS CUI [2]
C1554888
8. those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)
Descripción

Disease ophthalmologic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205481
9. those who have severe systemic disease (e.g. uncontrolled dm, hypertension, cardiovascular disease, cerebrovascular disease)
Descripción

Systemic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442893
10. those who refuse to submit written consent
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
11. those who cannot understand the contents of the clinical study and cooperate in the clinical trial
Descripción

clinical study; cooperation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008972
UMLS CUI [2]
C0392337
12. those who are pregnant or lactating women
Descripción

pregnant; Lactating

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
13. those who have a history of vitrectomy
Descripción

Vitrectomy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042903
14. those who require systemic corticosteroid or immunosuppressive agent treatment
Descripción

immunosuppressive agent; treatment systemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205373
15. those who are banned from using ozurdex
Descripción

ozurdex; prohibition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2702456
UMLS CUI [2]
C0683610
ocular infection or periocular infection
Descripción

Eye Infections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015403
advanced glaucoma
Descripción

advanced; glaucoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205179
UMLS CUI [2]
C0017601
hypersensitivity to dexamethasone or other component of ozurdex
Descripción

hypersensitivity; dexamethasone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0011777
posterior lens capsule rupture or aphakia
Descripción

Aphakia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003534
anterior chamber intraocular lens or posterior capsule rupture
Descripción

Posterior capsule rupture; Anterior chamber lens

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1535895
UMLS CUI [2]
C0441281
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Similar models

Eligibility Diabetes Mellitus NCT02399657

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Clinically significant macular edema; hard soapy exudates of retina
Item
1. patients diagnosed with csme (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center
boolean
C0730284 (UMLS CUI [1])
C2029279 (UMLS CUI [2])
best corrected visual acuity
Item
2. those who have a bcva (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)
boolean
C1690532 (UMLS CUI [1])
Macular grid.center point thickness
Item
3. those who have a central macular thickness on oct over 300 micrometer
boolean
C2735398 (UMLS CUI [1])
hard soapy exudates of retina
Item
4. if both eyes are eligible, eye having more hard exudates is selected (contralateral eye should be treated with corticosteroid other than ozurdex or focal laser photocoagulation, anti-vegf (vascular endothelial growth factor) injection is not allowed in contralateral eye)
boolean
C2029279 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Clinically significant macular edema; Without; hard soapy exudates of retina
Item
1. those who have csme without hard exudates
boolean
C0730284 (UMLS CUI [1])
C0332288 (UMLS CUI [2])
C2029279 (UMLS CUI [3])
Macular retinal edema
Item
2. those who have macular edema not related with diabetic retinopathy (e.g. amd (age-related macular degeneration), uveitis, retinal vein occlusion and untreated malignant hypertension)
boolean
C0271051 (UMLS CUI [1])
surgery intraocular
Item
3. those who have a history of intraocular surgery (e.g. cataract surgery) within 3 months
boolean
C0038894 (UMLS CUI [1,1])
C3282905 (UMLS CUI [1,2])
visual acuity; eye
Item
4. those who have a visual acuity of contralateral eye less than 0.1 (10/100)
boolean
C0042812 (UMLS CUI [1])
C0015392 (UMLS CUI [2])
Laser treatment; Retinal macula
Item
5. those who received focal laser treatment on macula within 3 months
boolean
C0850168 (UMLS CUI [1])
C0450295 (UMLS CUI [2])
Intravitreal Injections
Item
6. those who had intravitreal anti-vegf agent injection within 3 months
boolean
C1554888 (UMLS CUI [1])
triamcinolone; Intravitreal Injections
Item
7. those who had intravitreal triamcinolone injection within 6 months
boolean
C0040864 (UMLS CUI [1])
C1554888 (UMLS CUI [2])
Disease ophthalmologic
Item
8. those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)
boolean
C0012634 (UMLS CUI [1,1])
C0205481 (UMLS CUI [1,2])
Systemic disease
Item
9. those who have severe systemic disease (e.g. uncontrolled dm, hypertension, cardiovascular disease, cerebrovascular disease)
boolean
C0442893 (UMLS CUI [1])
informed consent
Item
10. those who refuse to submit written consent
boolean
C0021430 (UMLS CUI [1])
clinical study; cooperation
Item
11. those who cannot understand the contents of the clinical study and cooperate in the clinical trial
boolean
C0008972 (UMLS CUI [1])
C0392337 (UMLS CUI [2])
pregnant; Lactating
Item
12. those who are pregnant or lactating women
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Vitrectomy
Item
13. those who have a history of vitrectomy
boolean
C0042903 (UMLS CUI [1])
immunosuppressive agent; treatment systemic
Item
14. those who require systemic corticosteroid or immunosuppressive agent treatment
boolean
C0021081 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
ozurdex; prohibition
Item
15. those who are banned from using ozurdex
boolean
C2702456 (UMLS CUI [1])
C0683610 (UMLS CUI [2])
Eye Infections
Item
ocular infection or periocular infection
boolean
C0015403 (UMLS CUI [1])
advanced; glaucoma
Item
advanced glaucoma
boolean
C0205179 (UMLS CUI [1])
C0017601 (UMLS CUI [2])
hypersensitivity; dexamethasone
Item
hypersensitivity to dexamethasone or other component of ozurdex
boolean
C0020517 (UMLS CUI [1])
C0011777 (UMLS CUI [2])
Aphakia
Item
posterior lens capsule rupture or aphakia
boolean
C0003534 (UMLS CUI [1])
Posterior capsule rupture; Anterior chamber lens
Item
anterior chamber intraocular lens or posterior capsule rupture
boolean
C1535895 (UMLS CUI [1])
C0441281 (UMLS CUI [2])
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