UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized clinical trial of preventive effect of acetazormide acetate for marked intraocular pressure (IOP) elevation after cataract surgery in eyes with open-angle glaucoma.
Title of the study (Brief title)	Prevention of IOP elevation after cataract surgery in eyes with open-angle glaucoma
Region	Japan

Condition
Condition	Open-angle glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is known that a marked increase in intraocular pressure (IOP) occurs in some eyes with open-angle glaucoma. Although acetazormide acetate is occasionally administered for prevention of IOP elevation, it is still unclear when it should be taken to obtain the most prominent effects. The purpose of this study was to compare the changes in IOP after cataract surgery in eyes with open-angle glaucoma between patients who administer acetazormide acetate at 1 and 3 hours postoperatively.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1.IOP measured using a rebound tonometer (I care) in a supine position. 1) Preoperatively 2) At the conclusion of surgery..IOP is adjusted to a range between 15 and 25 mmHg. 3) 60 minutes postoperatively 4) 180 minutes postoperatively 5) 300 minutes postoperatively 6) 420 minutes postoperatively 7) 24 hours postoperatively
Key secondary outcomes	2. Postoperative inflammation Flare intensity at 5 hours postoperatively 3. Wound status Anterior segment-optical coherence tomography at 5 hours postoperatively 4. Others Visual acuity, refraction, corneal astigmatism

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1) Administering 2 tablets of acetadormide acetate for the first operated eye at 1 hour preoperatively, 30 eyes, 30 patients.
Interventions/Control_2	2) Administering 2 tablets of acetadormide acetate for the first operated eye at 1 hour preoperatively, 30 eyes, 30 patients.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with open-angle glaucoma of 40 years or older
Key exclusion criteria	1)macular or corneal pathology 2)history of ocular surgery and inflammation 3)pupil diameter of less than 5.0mm when dilated 4)any difficulty in follow-up or examination
Target sample size	90

Research contact person
Name of lead principal investigator	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of Ophthalmology
Address	4-23-35, Hakataekimae, Hakata-ku,
TEL	092-431-1680
Email	hayashi-ken@hayashi.or.jp

Public contact
Name of contact person	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of Ophthalmology
Address	4-23-35, Hakataekimae, Hakata-ku,
TEL	092-431-1680
Homepage URL
Email	hayashi-ken@hayashi.or.jp

Sponsor
Institute	Hayashi Eye Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 27 Day
Anticipated trial start date	2014 Year 09 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 12 Day
Last modified on	2016 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020302