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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017526
Receipt No. R000020302
Scientific Title Randomized clinical trial of preventive effect of acetazormide acetate for marked intraocular pressure (IOP) elevation after cataract surgery in eyes with open-angle glaucoma.
Date of disclosure of the study information 2015/05/13
Last modified on 2016/08/06

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Basic information
Public title Randomized clinical trial of preventive effect of acetazormide acetate for marked intraocular pressure (IOP) elevation after cataract surgery in eyes with open-angle glaucoma.
Acronym Prevention of IOP elevation after cataract surgery in eyes with open-angle glaucoma
Scientific Title Randomized clinical trial of preventive effect of acetazormide acetate for marked intraocular pressure (IOP) elevation after cataract surgery in eyes with open-angle glaucoma.
Scientific Title:Acronym 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
1st name
Middle name
Last name Ken Hayashi
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Zip code
Address 4-23-35, Hakataekimae, Hakata-ku,
TEL 092-431-1680
Email hayashi-ken@hayashi.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Hayashi
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 08 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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