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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040639 |
Receipt No. | R000046383 |
Scientific Title | A comparative study of the usefulness of the complete occlusion method and the incomplete occlusion method in functional amblyopia |
Date of disclosure of the study information | 2020/06/03 |
Last modified on | 2020/06/03 |
Basic information | ||
Public title | Comparison of complete and incomplete occlusion methods in amblyopia | |
Acronym | Comparison of occlusive methods for amblyopia | |
Scientific Title | A comparative study of the usefulness of the complete occlusion method and the incomplete occlusion method in functional amblyopia | |
Scientific Title:Acronym | Comparison of complete and incomplete occlusion methods in amblyopia | |
Region |
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Condition | ||
Condition | amblyopia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | A comparative study of the usefulness of the complete occlusion method and the incomplete occlusion method in functional amblyopia. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | visual acuity improvement period |
Key secondary outcomes | Visual acuity
refraction value Accommodating paralysis refraction value Eye position Stereoacuity |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Continue complete occlusion occlusion treatment until vision is restored to 1.0 | |
Interventions/Control_2 | Continue imcomplete occlusion occlusion treatment nis restored to 1.0 | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients diagnosed with functional amblyopia with no eye diseases other than refractive error | |||
Key exclusion criteria | 1. Those with eye movement restriction (abduction restriction)
2. Cranial MRI or CT reveals intracranial disease or intraorbital disease 3. Those who have already been diagnosed at another hospital and have already started treatment 4. What the researcher deems inappropriate |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kitasato University hospital | ||||||
Division name | Ophthalmology | ||||||
Zip code | 2520375 | ||||||
Address | 1-15-1 Kitasato, Minami-ku, Sagamihara | ||||||
TEL | 0427788111 | ||||||
satoru.totsuka@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Kitasato university hospital | ||||||
Division name | Ophthalmology | ||||||
Zip code | 2520375 | ||||||
Address | 1-15-1 Kitasato, Minami-ku, Sagamihara | ||||||
TEL | 0427788429 | ||||||
Homepage URL | |||||||
satoru.totsuka@gmail.com |
Sponsor | |
Institute | Kitasato university hospital |
Institute | |
Department |
Funding Source | |
Organization | Kitasato university hospital |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | JPN |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kitasato university hospital |
Address | 1-15-1 Kitasato, Minami-ku, Sagamihara |
Tel | 0427788111 |
satoru.totsuka@gmail.com |
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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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
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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=R000046383 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |