UMIN-ICDS 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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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