UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042733 |
|---|---|
| Receipt number | R000048769 |
| Scientific Title | Clinical outcomes of scleral intraocular lens fixation |
| Date of disclosure of the study information | 2020/12/17 |
| Last modified on | 2021/12/13 21:03:46 |
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Basic information
Public title
Clinical outcomes of scleral intraocular lens fixation
Acronym
Clinical outcomes of scleral intraocular lens fixation
Scientific Title
Clinical outcomes of scleral intraocular lens fixation
Scientific Title:Acronym
Clinical outcomes of scleral intraocular lens fixation
Region
| Japan |
Condition
Condition
aphakia, intralocular lens dislocation, lens dislocation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To report the clinical outcomes of intrascleral fixation of an intraocular lens
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular lens dislocation, tilt
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intraocular lens haptic is pulled out of the sclera by the single needle method.
Interventions/Control_2
The intraocular lens haptic is pulled out of the sclera by the double needle method.
Interventions/Control_3
The intraocular lens haptic is pulled out of the sclera by the vitreous forceps.
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
| 120 | years-old | > |
Gender
Male
Key inclusion criteria
Patients in which visual function is impaired due to aphakia, intraocular lens dislocation, lens dislocation.
Key exclusion criteria
The exclusion criteria were retinal disease requiring treatment, such as retinal detachment or macular pucker; preoperative intraocular pressure (IOP) of 25 mmHg or more while receiving treatment with eye drops; scleritis;
age younger than 20 years
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tatsushi |
| Middle name | |
| Last name | Kaga |
Organization
Chukyo Hospital
Division name
Opthalomology
Zip code
4578510
Address
1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aichi
TEL
052-691-7151
kaga@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Mitamura |
Organization
Chukyo Hospital
Division name
Opthalomology
Zip code
4578510
Address
1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aichi
TEL
052-691-7151
Homepage URL
mitamura@chukyogroup.jp
Sponsor or person
Institute
Chukyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Chukyo Hospital
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
Japan Community Health care Organization
Address
1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aic
Tel
052-691-7151
mitamura@chukyogroup.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020019
Org. issuing International ID_1
Chukyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
63
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048769
