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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000035091 |
Receipt No. | R000040004 |
Official scientific title of the study | Temporal Inverted Internal Limiting Membrane Flap Technique for refractory Macular Holes |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2018/11/30 |
Basic information | ||
Official scientific title of the study | Temporal Inverted Internal Limiting Membrane Flap Technique for refractory Macular Holes | |
Title of the study (Brief title) | Temporal Inverted ILM Flap Technique | |
Region |
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Condition | |||
Condition | Macular hole | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluation of the efficacy of temporal inverted internal limiting membrane flap technique for macular holes |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The final rate of macular hole closure |
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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | refractory MHs, including large MHs (minimal diameter, over 400 micro meter), chronic MHs (symptomatic duration, over 24 months), MHs in high myopia (axial length, over 26 mm), and MHs in patients who could not maintain postoperative prone positioning after vitrectomy | |||
Key exclusion criteria | Patients with a history of retinal surgery, retinal detachment, diabetic retinopathy, retinal vascular occlusion, uveitis, and trauma were excluded. | |||
Target sample size | 40 |
Research contact person | |
Name of lead principal investigator | Yasuyuki Takai |
Organization | Shimane university |
Division name | Ophthalmology |
Address | Enya 89-1, Izumo, Shimane |
TEL | 0853-20-2284 |
takai611@med.shimane-u.ac.jp |
Public contact | |
Name of contact person | Yasuyuki Takai |
Organization | Shimane university |
Division name | Ophthalmology |
Address | Enya89-1, Izumo, Shimane |
TEL | 0853-20-2284 |
Homepage URL | |
takai611@med.shimane-u.ac.jp |
Sponsor | |
Institute | Shimane university |
Institute | |
Department |
Funding Source | |
Organization | Shimane university |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
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 |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Partially published |
URL releasing results | |
Results | |
Other related information | The MHs closed successfully in all (100%) eyes postoperatively in 20 refractory macular hole patients. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040004 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |