UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022608 |
|---|---|
| Receipt number | 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 19:32:28 |
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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
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
amanibadawi37@yahoo.com
Sponsor or person
Institute
Mansoura University-Faculty of Medicine
Mansoura Ophthalmic center
Ophthalmology department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026059
