UMIN ID: C000000455
Registered date:27/07/2006
A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | diabetic retinopathy |
Date of first enrollment | 2006/07/01 |
Target sample size | 40 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | A single sub-Tenon's injection of triamcinolone acetonide (20mg) and panretinal photocoagulation Panretinal photocoagulation |
Outcome(s)
Primary Outcome | Best-corrected visual acuity (logarithm of the minimum angle of resolution) at 6 months after treatment |
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Secondary Outcome | Best-corrected visual acuity (logMAR) at 1,3 months after treatment Foveal thickness at 1week, 1,3,6 months after treatment Intraocular pressure at 1,3,6 months after treatment |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | (1)Intraocular pressure is more than 21 mmHg (2)Massive cataract (3)Ocular pathology other than diabetic retinopathy (e.g., glaucoma, age-related macular degeneration) (4)Tractional retinal detachment or massive proliferation (5)Vitreous hemorrhage (6)Unilateral or asymmetrical diabetic retinopathy (7)Neovascular glaucoma (8)Previous vitreoretinal surgery (9)Previous panretinal photocoagulation (10)Pregnant or lactating women |
Related Information
Primary Sponsor | Kyoto University Graduate School of Medicine, Department of Ophthalmology |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Noriyuki Unoki |
Address | 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan Japan |
Telephone | 075-751-3250 |
noriharu@kuhp.kyoto-u.ac.jp | |
Affiliation | Kyoto University Graduate School of Medicine Department of Ophthalmology |
scientific contact | |
Name | Mihori Kita |
Address | 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan Japan |
Telephone | 075-751-3250 |
Affiliation | Kyoto University Graduate School of Medicine Department of Ophthalmology |