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

UMIN ID: C000000455

Registered date:27/07/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• 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
• 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
• Age maximum: Not applicable
• Gender: Male and Female
• 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
• Source(s) of Monetary Support: None