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1370 Final Protocol to guide the assessment of optical coherence tomography for the determination of eligibility and efficacy assessment of treatment with ocriplasmin (JETREA®) May 2014
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Document Date: 2014-10-27 00:38:23


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File Size: 1,94 MB

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Carl Zeiss Pty Ltd / Australian Vitreo / ARTG Number Sponsor Device 194817 Optos Australia Pty Ltd / Canon Australia Pty Ltd / Alcon Laboratories (Australia) Pty Ltd / Brien Holden Vision Pty Ltd / AMD / Optech Diagnostic & Surgical Pty Ltd / /

Country

Australia / United Kingdom / /

Currency

USD / /

Facility

National Eye Institute / New Zealand College of Ophthalmologists / Royal College of Ophthalmologists / /

IndustryTerm

patient requiring anaesthetic services / stand-alone mobile equipment / anaesthetic services / therapies for the same disease / drug product / Time domain technology / retinal and macular imaging / subjective diagnostic tool / cancer treatment / clinical management / imaging / trademarked technology / proposed management algorithms / recent spectral domain systems / coherence tomography systems / generation systems / health insurance / healthcare resources / clear and colourless solution / diagnostic tool / /

MedicalCondition

glaucoma / lamellar macular holes / macular holes / vitreous haemorrhage endophthalmitis / eye movement disorder / nominated macular hole / Vitreomacular interface disorders / intraocular inflammation / macular and retinal diseases / retinal diseases / macular and retinal disease / endophthalmitis / post-operative cataract / metamorphopsia / tractional diseases / vitreoretinal interface disorders / posterior vitreous detachment / e.g. cataracts / VMA/VMT/FTMH disease / wet Age-Related Macular Degeneration / macular hole / pre-existing glaucoma Endophthalmitis Retinal tear / central retinal vein occlusion / cataracts / disease / epiretinal membrane / retinal vascular disease / full thickness macular holes / full thickness macular hole / macular disease / cognitive impairment / macular epiretinal membrane / same disease / baseline macular hole / focal VMA Macular hole / large macular holes / diseases / retinal vein occlusion / VMT/FTMH disease / macular epiretinal membranes / inflammation / central blindness / cataract / retinal tear / /

MedicalTreatment

invasive procedure / surgery / invasive surgery / drug therapy / /

Organization

National Eye Institute / Royal College of Ophthalmologists / Royal Australian and New Zealand College of Ophthalmologists / Therapeutic Goods Administration / Advisory board / Medicare / Department of Veteran / PBS Authority / Department of Health / Medical Services Advisory Committee / /

Position

medical retinal specialist / Commonwealth Minister / consultant physician / masked Investigator / Governor / surgeon / Government Health Minister / /

Product

pseudo / INTRAVITREAL INJECTION / sodium chloride / LUCENTIS / /

Technology

diagnostic tests / tomography / trademarked technology / Time domain technology / 7 Proposed Clinical Management Algorithm / ultrasound / draft Protocol / tomography system / proposed management algorithms / 1370 Final Protocol / recombinant DNA technology / /

URL

http /

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