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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022608
Receipt No. R000026059
Scientific Title Efficacy of topical dorzolamide 2% in diabetic cystoid macular edema
Date of disclosure of the study information 2016/06/05
Last modified on 2016/06/04

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Basic information
Public title Efficacy of topical dorzolamide 2% in diabetic cystoid macular edema
Acronym Topical dorzolamide 2% in diabetic cystoid macular edema
Scientific Title Efficacy of topical dorzolamide 2% in diabetic cystoid macular edema
Scientific Title:Acronym Topical dorzolamide 2% in diabetic cystoid macular edema
Region
Africa

Condition
Condition Diadetic cystoid maculopathy at Mansoura Ophthalmic center -Egypt
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of topical dorzolamide 2% in treating cystoids macular edema in diabetic patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Eefective in reduction central foveal
thickness
Key secondary outcomes Improvement of BCVA

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Details of interventions: Application of dorzolamide 2% eye drop 2% In diabetic cystoid edema
Amount, and frequency:3 times /day
Duration:for 30 days
Follow up for 3 months
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
40 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria The diabetic adult patients (type 1 and 2) with cystoids macular edema (CSME) secondary to diabetic retinopathy
Key exclusion criteria Patients had additional ocular diseases (chronic inflammatory, glaucoma, or neoplastic disorders,Patients on other medications may affect the visual acuity and/or retinal function, Advanced diabetic eye disease,Serous retinal detachment,Vitreo-retinal traction syndrome,Mixed maculopathy (macular ischemia by angiography),Prior laser therapy.
Target sample size 93

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Amani Elsayed Badawi
Organization Mansoura University-Faculty of Medicine
Mansoura Ophthalmic center
Division name Ophthalmology
Zip code
Address 60 gomhoria street-Mansoura universith -Mansoura-Egypt
TEL 0201003818271
Email amanibadawi37@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Amani Badwi
Organization Mansoura University-Faculty of Medicine Mansoura Ophthalmic center Ophthalmology department
Division name Ophthalmology department
Zip code
Address 60 gomhoria street-Mansoura universith -Mansoura-Egypt
TEL 0201003818271
Homepage URL
Email amanibadawi37@yahoo.com

Sponsor
Institute Mansoura University-Faculty of Medicine
Mansoura Ophthalmic center
Ophthalmology department
Institute
Department

Funding Source
Organization Mansoura University-Faculty of Medicine
Mansoura Ophthalmic center
Ophthalmology department
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 Mansoura University-Faculty of Medicine
Mansoura Ophthalmic center

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 05 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 08 Day
Last follow-up date
2015 Year 05 Month 10 Day
Date of closure to data entry
2015 Year 06 Month 30 Day
Date trial data considered complete
2015 Year 08 Month 02 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 04 Day
Last modified on
2016 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026059

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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