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Common Data Elements for Retinal Neovascular Diseases - Risk Factors or Past Medical History

- 20/09/2021 - 4 Formulieren, 1 Itemgroep, 35 Data-elementen, 2 Talen
Itemgroep: Risk Factors; Past Medical History
Common Data Elements for retinal neovascular diseases. The CDEs may be used in clinical routine, clinical trial, patient outcome, quality assurance and registry documentation of Age related macular degeneration (AMD), Diabetic Retinopathy (DR) and Retinal vein occlusion (RVO). The CDEs were developed by the Institute of Medical Informatics of the University Muenster in cooperation with the Department of Ophthalmology of the University Hospital Muenster.

Diagnosis and Examination

1 Itemgroep 11 Data-elementen

Eye Examination

1 Itemgroep 18 Data-elementen

Therapy

1 Itemgroep 9 Data-elementen

Demographics Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Demographics Screening

- 17/09/2021 - 1 Formulier, 1 Itemgroep, 7 Data-elementen, 1 Taal
Itemgroep: Demography
Study part: Demographics Screening . A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Eligibility NCT01012973 Retinal Vein Occlusion - Eligibility

- 17/09/2021 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 2 Talen
Itemgroepen: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01012973

4 Meter Visual Acuity/ Right Eye Chart 1 Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - 4 Meter Visual Acuity/ Right Eye Chart 1 Day 0

- 18/03/2018 - 1 Formulier, 4 Itemgroepen, 28 Data-elementen, 1 Taal
Itemgroepen: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Right Eye Chart 1 Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Vital Signs Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Vital Signs Day 0

- 18/03/2018 - 1 Formulier, 1 Itemgroep, 11 Data-elementen, 1 Taal
Itemgroep: Vital Signs
Study part: Vital Signs Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Language Used for Patient- Reported Outcome Questionnaires Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Language Used for Patient- Reported Outcome Questionnaires Day 0

- 18/03/2018 - 1 Formulier, 1 Itemgroep, 4 Data-elementen, 1 Taal
Itemgroep: language
Study part: Language Used for Patient- Reported Outcome Questionnaires Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Intraocular Pressure Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Intraocular Pressure Screening

- 18/03/2018 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal
Itemgroep: Intraocular Pressure
Study part: Intraocular Pressure Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Indirect Ophthalmoscopy Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Indirect Ophthalmoscopy Screening

- 18/03/2018 - 1 Formulier, 4 Itemgroepen, 52 Data-elementen, 1 Taal
Itemgroepen: Indirect Ophthalmoscopy Right Eye, Indirect Ophthalmoscopy Left Eye , Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Slitlamp Examination Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Slitlamp Examination Screening

- 18/03/2018 - 1 Formulier, 4 Itemgroepen, 44 Data-elementen, 1 Taal
Itemgroepen: Slitlamp Examination Right Eye, Slitlamp Examination Left Eye , Findings of Inflammation right eye, Findings of Inflammation left eye
Study part: Slitlamp Examination Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

4 Meter Visual Acuity/ Left Eye Chart 2 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - 4 Meter Visual Acuity/ Left Eye Chart 2

- 18/03/2018 - 1 Formulier, 4 Itemgroepen, 28 Data-elementen, 1 Taal
Itemgroepen: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Left Eye Chart 2. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

4 Meter Visual Acuity/ Right Eye Chart 1 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - 4 Meter Visual Acuity/ Right Eye Chart 1

- 18/03/2018 - 1 Formulier, 4 Itemgroepen, 28 Data-elementen, 1 Taal
Itemgroepen: Visual acuity, Visual acuity, total score, Vision Tests
Study part: 4 Meter Visual Acuity/ Right Eye Chart 1. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Vital Signs Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Vital Signs Screening

- 18/03/2018 - 1 Formulier, 1 Itemgroep, 14 Data-elementen, 1 Taal
Itemgroep: Vital Signs
Study part: Vital Signs Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

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