UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017556 |
|---|---|
| Receipt number | R000020347 |
| Scientific Title | Randomized clinical trial of preventive effect of acetazormide acetate for marked intraocular pressure (IOP) elevation after cataract surgery in eyes with pseudoexfoliation syndrome. |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2018/06/22 12:08:50 |
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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 pseudoexfoliation syndrome.
Acronym
Prevention of IOP elevation after cataract surgery in eyes with pseudoexfoliation syndrome
Scientific Title
Randomized clinical trial of preventive effect of acetazormide acetate for marked intraocular pressure (IOP) elevation after cataract surgery in eyes with pseudoexfoliation syndrome.
Scientific Title:Acronym
Prevention of IOP elevation after cataract surgery in eyes with pseudoexfoliation syndrome
Region
| Japan |
Condition
Condition
pseudoexfoliation syndrome
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 pseudoexfoliation syndrome. 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 pseudoexfoliation syndrome 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 surger: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 pseudoexfoliation syndrome 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
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
hayashi-ken@hayashi.or.jp
Sponsor or person
Institute
Hayashi Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
林眼科病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 14 | 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
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 05 | 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 | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020347
