Unique ID issued by UMIN | UMIN000007522 |
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Receipt number | R000008865 |
Scientific Title | Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients |
Date of disclosure of the study information | 2012/04/01 |
Last modified on | 2012/03/18 10:12:29 |
Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Effect of bromfenac eye drops on ocular inflammation after cataract surgery in diabetic patients
Japan |
ocular inflammation after cataract surgery
Ophthalmology |
Others
NO
To compare bromfenac sodium alone to combination use of a steroidal ophtalmic solution in priventing ocular inflammation after cataract surgery in diabetic patients.
Efficacy
Confirmatory
Pragmatic
Phase IV
Clinical test items such as best corrected visual acuity, slit lamp microscopy, amount of anterior chamber flare and cells mesured laser flare cell photometry, corneal thickness and retinal thickness were recorded each visit, preoperatively, 2day, 1week, 2weeks, 4weeks, 8weeks after cataract surgery.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
2
Treatment
Medicine |
Bromfenac sodium was administrated to eye after cataract surgery two times per day for 1day to 8weeks.
Steroidal ophthalmic solution was administrated to eye after cataract surgery four times per day for 1day to 2weeks and bromfenac sodium was administrated two times per day for 1day to 8weeks.
20 | years-old | <= |
90 | years-old | > |
Male and Female
Diabetic patients(HbA1c over 6.0%) with cataract(Emery-Little classification grade4 or lower).
Eyes allergic to bromfenac or steroid, eyes previously and post operatively underwent intraocular surgery of any type, history of uveitis, patients with severe cardiac incompetence or cereberovascular disorder and patient undergo hemo dialysis.
60
1st name | |
Middle name | |
Last name | Kazunori Miyata |
Miyata eye hospital
department of ophthalmology
6-3 Kurahara-machi Miyakonojyo-shi, Miyazaki
0986-22-1441
1st name | |
Middle name | |
Last name | Yukiko Terada |
Miyata eye hospital
department of ophthalmology
terada@miyata-med.ne.jp
Miyata eye hospital
Miyata eye hospital
Self funding
NO
2012 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 01 | Month | 26 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2012 | Year | 03 | Month | 18 | Day |
2012 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008865
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