NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051200008

Registered date:28/04/2020

Human Vitreous Concentration of Brimonidine after Instillation of Aibeta Combination Ophthalmic Solution

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedIdiopathic epiretinal membrane, macular hole
Date of first enrollment04/06/2020
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)One drop of Brimonidine/Timolol fixed combination ophthalmic solution is instilled twice-daily for 8 days (7 days before surgery and the operation day in the morning and at 2h before surgery).

Outcome(s)

Primary OutcomeConcentration of brimonidine in the aqueous humor and vitreous
Secondary OutcomeConcentration of timolol in the aqueous humor and vitreous, Correlation between concentration of drugs in the aqueous humor and vitreous and patient background, adverse events, visual acuity, intraocular pressure, blood pressure, pulse, ophthalmologic findings (cornea, conjunctiva)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1)Patients with written informed consent obtained after adequate explanation on participating the study 2)Male or female, 20 years of age or older 3)Patients who undergo vitrectomy for idiopathic epiretinal membrane or macular hole
Exclude criteria1)Patients with ocular inflammation 2)Patients with vitreous hemorrhage 3)Patients with proliferative diabetic retinopathy 4)Patients with severe corneal epithelium disorder 5)Patients with contraindications or patients in whom precautions are required for the use of Brimonidine/Timolol fixed combination. 6)Patients with a history of serious side effects against alpha 2-adrenergic receptor agonist or beta-adrenergic receptor inhibitor 7)Patients who have been considered inappropriate as study subjects by doctor

Related Information

Contact

Public contact
Name Masaru Inatani
Address 23-3 Matsuoka-Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui, Japan Fukui Japan 910-1193
Telephone +81-776-61-8403
E-mail inatani@u-fukui.ac.jp
Affiliation University of Fukui Hospital
Scientific contact
Name Masaru Inatani
Address 23-3 Matsuoka-Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui, Japan Fukui Japan 910-1193
Telephone +81-776-61-8403
E-mail inatani@u-fukui.ac.jp
Affiliation University of Fukui Hospital