NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studieddiabetic retinopathy
Date of first enrollment2006/07/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A single sub-Tenon's injection of triamcinolone acetonide (20mg) and panretinal photocoagulation Panretinal photocoagulation

Outcome(s)

Primary OutcomeBest-corrected visual acuity (logarithm of the minimum angle of resolution) at 6 months after treatment
Secondary OutcomeBest-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 minimum20years-old
Age maximumNot applicable
GenderMale 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

Contact

public contact
Name Noriyuki Unoki
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan Japan
Telephone 075-751-3250
E-mail 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
E-mail
Affiliation Kyoto University Graduate School of Medicine Department of Ophthalmology