UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043141 |
|---|---|
| Receipt number | R000049213 |
| Scientific Title | Clinical evaluation of combined minimally invasive glaucoma surgery and cataract surgery using toric intraocular lens |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/01/27 08:40:10 |
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Basic information
Public title
Clinical evaluation of combined minimally invasive glaucoma surgery and cataract surgery using toric intraocular lens
Acronym
MIGS using toric intraocular lens
Scientific Title
Clinical evaluation of combined minimally invasive glaucoma surgery and cataract surgery using toric intraocular lens
Scientific Title:Acronym
MIGS using toric intraocular lens
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the refractive status between eyes implanted with toric and non-toric intraocular lenses (IOLs) during combined cataract and microhook ab interno trabeculotomy, a minimally invasive glaucoma surgery (MIGS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes were the uncorrected visual acuity (UCVA) and refractive cylinder at 3 months postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
toric IOL
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had open-angle glaucoma, cataract, and pre-existing regular corneal astigmatism exceeding 1.5 diopters, and underwent combined micro LOT and phacoemulsification were recruited retrospectively.
Key exclusion criteria
Eyes were included that had no history of a previous intraocular surgery, no central visual field defect due to glaucoma, no complications during combined micro LOT and cataract surgery, and no postoperative interventions.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YASUYUKI |
| Middle name | |
| Last name | TAKAI |
Organization
Shimane University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
6938501
Address
Enya89-1, Izumo, Japan
TEL
0853-20-2284
takai611@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | YASUYUKI |
| Middle name | |
| Last name | TAKAI |
Organization
Shimane University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
6938501
Address
Enya89-1, Izumo, Japan
TEL
0853-20-2284
Homepage URL
takai611@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan Ltd. (Tokyo, Japan)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Shimane University Hospital
Address
Enya 89-1, Izumo, Japan
Tel
0853-20-2259
kenkyu@med.shimane-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049213
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
