UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011069 |
|---|---|
| Receipt number | R000012959 |
| Scientific Title | Prospective study for glaucoma surgery outcome |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2022/08/01 16:38:36 |
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Basic information
Public title
Prospective study for glaucoma surgery outcome
Acronym
Prospective study for glaucoma surgery
Scientific Title
Prospective study for glaucoma surgery outcome
Scientific Title:Acronym
Prospective study for glaucoma surgery
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively analyze intraocular pressure lowering effects and frquency of complications after various glaucoma surgical techniques
Basic objectives2
Others
Basic objectives -Others
A variety of surgical approachs are applied aming at lowering intraocular pressure (IOP) in glaucomatous eyes. Trabeculectomy and implant surgery are most common among them. Amniotic membrane transplantation is adjunctively used for trabeculectomy in refractory glaucoma. However, the difference in mid- to long-term outocome in terms of IOP lowering and frequency of complications such as corneal endothelial decompensation and hypotony maculopathy among these surgeries have not been elucidated. The purpose of this study is to register all eyes that are subject to undergo any tyeps of glaucoma surgeries and prospectively compare the IOP lowering outcomes and frquencies of complications among surgeries.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival table analysis of intraocular presssure
Key secondary outcomes
Time course changes in axial length, corneal endothelium, refractive error, choroidal thickness, hypotony maculopathy,best-corrected visual acuity, choroidal detachment, bleb leakage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
trabeculectomy
Interventions/Control_2
amniotic membrane-assisted trabeculectomy
Interventions/Control_3
Glaucoma implant surgery
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
| 10 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Glaucomatous eyes with visual function, in which maximal tolerable medicines cannot reach target intraocular pressure
Key exclusion criteria
Eyes without visual function. Children under 10 years old. Individuals who are unexpected be visit regular follow up after surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nakamura |
Organization
Kobe University Graduate School of Medicine, Department of Surgery
Division name
Ophthalmology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
manakamu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Nakamura |
Organization
Kobe University Graduate School of Medicine, Department of Surgery
Division name
Ophthalmology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
Homepage URL
manakamu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Department of Surgery Division of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine, Department of Surgery Division of Ophthalmology
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
Kobe University Hospital Clinical and Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
0783826669
kansatsu@med.kobe-u.ac.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
神戸大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00417-018-4044-3
Number of participants that the trial has enrolled
Results
Sulcus fixation of BGIs may be effective and safe in patients with glaucomatous eyes who underwent multiple prior intraocular surgeries.
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
| 2013 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012959
