UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036502
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ismail.omar@mu.edu.eg

Sponsor
Institute ophthalmology departement, faculty of medicine, Minia university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041589

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.