UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036502 |
|---|---|
| Receipt number | R000041589 |
| Scientific Title | Evaluation of Ciliary Body by Ultrasound Bio-microscopy after Trans-scleral Diode Cyclophotocoagulation in Refractory Glaucoma |
| Date of disclosure of the study information | 2019/04/13 |
| Last modified on | 2019/04/13 19:14:16 |
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Basic information
Public title
Evaluation of Ciliary Body by Ultrasound Bio-microscopy after Trans-scleral Diode Cyclophotocoagulation in Refractory Glaucoma
Acronym
Evaluation of Ciliary Body by Ultrasound Bio-microscopy after Trans-scleral Diode Cyclophotocoagulation in Refractory Glaucoma
Scientific Title
Evaluation of Ciliary Body by Ultrasound Bio-microscopy after Trans-scleral Diode Cyclophotocoagulation in Refractory Glaucoma
Scientific Title:Acronym
Evaluation of Ciliary Body by Ultrasound Bio-microscopy after Trans-scleral Diode Cyclophotocoagulation in Refractory Glaucoma
Region
| Africa |
Condition
Condition
refractory glaucoma patients
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate morphological changes of the ciliary body after diode laser trans-scleral cyclo-photocoagulation (TSCPC) using Ultrasound Bio-microscopy (UBM) in refractory glaucoma.
Basic objectives2
Others
Basic objectives -Others
intraocular pressure reduction in relation to ciliary body changes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reduction of intra-ocular pressure
Key secondary outcomes
changes in the ciliary processes in relation to intraocular pressure reduction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
using ultrasound biomicroscopy to examine eyes of refractory glaucoma before being treated with trans-scleral cyclophotocoagulation and one week, one months, and three months postoperatively
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
refractory glaucoma
Key exclusion criteria
previous cyclodestructive procedure
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ismail |
| Middle name | Ahmed |
| Last name | Omar |
Organization
Minia university hospital
Division name
minia university
Zip code
61111
Address
kornish el-nile
TEL
+201002554116
ismail.omar@mu.edu.eg
Public contact
Name of contact person
| 1st name | ismail |
| Middle name | ahmed |
| Last name | omar |
Organization
Minia university hospital
Division name
minia university
Zip code
61111
Address
kornish el-nile
TEL
+201002554116
Homepage URL
ismail.omar@mu.edu.eg
Sponsor or person
Institute
ophthalmology departement, faculty of medicine, Minia university
Institute
Department
Personal name
Funding Source
Organization
self
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
Faculty of Medicine, minia university
Address
El-minya, Egypt
Tel
+20862347460
med.prt@mu.edu.eg
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
| 2019 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
40
Results
TSCPC is a rapid and effective procedure in treatment of refractory glaucoma with IOP reduction. UBM is a promising twin tool for cyclo-destructive procedures to detect ciliary body changes and can be used as a guide for retreatment procedures
Results date posted
| 2019 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
age between 40 and 70
Participant flow
no drop outs and they were cooperative to come in the follow up
Adverse events
non
Outcome measures
IOP reduction
changes in the ciliary processes length and width in addition to the ciliary muscle thickness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041589
