UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053665 |
|---|---|
| Receipt number | R000061248 |
| Scientific Title | Surgical outcome of glaucoma drainage device into the ciliary sulcus |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2024/04/08 18:47:45 |
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Basic information
Public title
Surgical outcome of glaucoma drainage device into the ciliary sulcus
Acronym
Surgical outcome of glaucoma drainage device into the ciliary sulcus
Scientific Title
Surgical outcome of glaucoma drainage device into the ciliary sulcus
Scientific Title:Acronym
Surgical outcome of glaucoma drainage device into the ciliary sulcus
Region
| Japan |
Condition
Condition
primary open angle glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate surgical outcome of glaucoma drainage device into the ciliary sulcus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure
Tube fixation position
Iris malposition
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
IOP >21 or higher
Pseudophakic eye
Glaucoma cases requiring glaucoma tube shunt surgery
Key exclusion criteria
Corneal endothelial cell density less than 1500/mm2
Lensed eye Aphakic eye
Cases in which other tube shunt surgery is not indicated
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennnojiku, Osaka
TEL
81-6-6774-5111
masayuki@akimoto3.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennnojiku, Osaka
TEL
81-6-6774-5111
Homepage URL
masayuki@akimoto3.com
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Red Cross Hospital
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
Osaka Red Cross Hospital Medical Ethics Review Committee
Address
5-30 Fudegasakicho, Tennojiku, Osaka
Tel
+81667745111
soumudaiichi@osaka-med.jrc.or.jp
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
| 2024 | Year | 02 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ciliary sulcus insertion of glaucoma drainage devices is said to be safer than anterior chamber insertion, but the effects of the tube on iris shape and interference within the pupil have been reported
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061248
