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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007453
Receipt No. R000008759
Scientific Title The effect of topical dorzolamide for macular edema
Date of disclosure of the study information 2012/03/06
Last modified on 2012/03/06

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Basic information
Public title The effect of topical dorzolamide for macular edema
Acronym The effect of topical dorzolamide for macular edema
Scientific Title The effect of topical dorzolamide for macular edema
Scientific Title:Acronym The effect of topical dorzolamide for macular edema
Region
Japan

Condition
Condition macular edema after vitrectomy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of topical dorzolamide for macular Edema after vitrectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, intraocular pressure, central macular thickness, and aqueous flare
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Topical dorzolamide was administrated to eye after vitrectomy three times per day.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patient with macular edema after vitrectomy
Key exclusion criteria Any patients with preexisting ocular disease (glaucoma, high myopia, chronic inflammatory, or neoplastic disorders), systemic disorders (diabetes or uncontrolled hypertension), a known lifethreatening disease, or eyes allergic to dorzolamide were excluded.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Kawai
Organization Tokai University School of Medicine
Division name Department of Opthalmology
Zip code
Address 143, Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Suzuki
Organization Tokai University School of Medicine
Division name Ophthalmology
Zip code
Address 143, Shimokasuya, Isehara, Kanagawa, 259-1193, Japan
TEL
Homepage URL
Email

Sponsor
Institute Tokai University School of Medicine, Department of Ophthalmology
Institute
Department

Funding Source
Organization Tokai University School of Medicine, Department of Ophthalmology
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
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
2012 Year 03 Month 06 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 No longer recruiting
Date of protocol fixation
2006 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 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
2012 Year 03 Month 06 Day
Last modified on
2012 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008759

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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