UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037838 |
|---|---|
| Receipt number | R000043140 |
| Scientific Title | Heads-up 3D ophthalmologic surgery under low light intensity conditions |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2019/08/28 20:55:10 |
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Basic information
Public title
Heads-up 3D ophthalmologic surgery under low light intensity conditions
Acronym
Heads-up 3D ophthalmologic surgery under low light intensity conditions
Scientific Title
Heads-up 3D ophthalmologic surgery under low light intensity conditions
Scientific Title:Acronym
Heads-up 3D ophthalmologic surgery under low light intensity conditions
Region
| Japan |
Condition
Condition
cataract, vitreo-retinal disorders, glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, 3D surgery has been largely performed in ophthalmic field. Compared to conventional microscopes, it provides surgery under low light condition that is not dazzling for patients, and also safer to intraocular tissues concerning retinal phototoxicity. The purpose of this study is to confirm and determine the feasibility of performing intraocular surgeries in a heads-up position with low illuminance conditions by evaluating the recorded images. Also, we evaluate whether the operating microscope light was uncomfortable or not by the records of the patients information retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[ Safety / Efficacy] Confirm and determine the feasibility of performing intraocular surgeries in a heads-up position with low illuminance conditions by evaluating the recorded images.
[ Amenity ] Evaluate whether the operating microscope light was uncomfortable or not by the records of the patients information retrospectively.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria includes patient that received cataract surgery, glaucoma surgery, vitreo-retinal surgery under local anesthesia with 3D heads-up system.
Key exclusion criteria
Patients with severe general illness, or with deficiency to communicate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Souichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Matsumoto Eye Clinic
Division name
Ophthalmology
Zip code
771-1705
Address
Tokushima Prefecture Awa-shi Awa-cho Takagaki 50
TEL
0883-35-7128
soiti@me.com
Public contact
Name of contact person
| 1st name | Souichi |
| Middle name | |
| Last name | Matsumoto |
Organization
Matsumoto Eye Clinic
Division name
Ophthalmology
Zip code
771-1705
Address
Tokushima Prefecture Awa-shi Awa-cho Takagaki 50
TEL
0883-35-7128
Homepage URL
soiti@me.com
Sponsor or person
Institute
Matsumoto Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Matsumoto Eye Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsumoto Eye Clinic
Address
Tokushima Prefecture Awa-shi Awa-cho Takagaki 50
Tel
0883-35-7128
soiti@me.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
| 2019 | Year | 08 | Month | 28 | 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
56
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing to be related
Management information
Registered date
| 2019 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043140
