UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of topical dorzolamide 2% in diabetic cystoid macular edema
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Amani Elsayed Badawi
Organization	Mansoura University-Faculty of Medicine Mansoura Ophthalmic center
Division name	Ophthalmology
Address	60 gomhoria street-Mansoura universith -Mansoura-Egypt
TEL	0201003818271
Email	amanibadawi37@yahoo.com

Public contact
Name of contact person	Amani Badwi
Organization	Mansoura University-Faculty of Medicine Mansoura Ophthalmic center Ophthalmology department
Division name	Ophthalmology department
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
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

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Publication of results	Unpublished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