UMIN ID: UMIN000000711
Registered date:01/07/2007
Priventive effect of Bromfenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | macular edema after cataract surgery |
| Date of first enrollment | 2006/03/01 |
| Target sample size | 80 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Bromfenac sodium was administrated to eye after cataract surgery two times per day for 1day to 6weeks. Steroidal ophtalmic sorution was administrated to eye after cataract surgery four times per day for 1day to 6weeks. |
Outcome(s)
| Primary Outcome | Best corrected visual acuity, slit lamp microscopy, amount of anterior chamber flare and cells mesured laser flare cell photometry. Retinal thickness and foveal volum ware mesured by OCT3 recorded each visit,preoperatively, 1day, 1week,2weeks, 4weeks, 6weeks after cataract surgery. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 35years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Eyes of sever diabetic retinopathy, eyes allergic to bromfenac or steroid, eyes previously and post operatively underwent intraocular surgery of auy type, history of uveitis or presence of any retinal choloidal disease other than diabeties, patient with severe cardiac incompetence or cereberovascular disorder and patient undergo hemo dialysis. |
Related Information
| Primary Sponsor | Tokyo women's medical university diabetic center opthalmology depertment |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Tokyo women's medical university diabetic center opthalmology depertment |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| endo@dmc.twmu.ac.jp | |
| Affiliation | Tokyo women's medical university diabetic center opthalmology depertment Tokyo women's medical university diabetic center opthalmology depertment |
| scientific contact | |
| Name | shigehiko kitano |
| Address | shinjukuku kawadacho 8-1 Japan |
| Telephone | |
| Affiliation | Tokyo women's medical university diabetic center opthalmology depertment Tokyo women's medical university diabetic center opthalmology depertment |