UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044350 |
|---|---|
| Receipt number | R000048780 |
| Scientific Title | Intrascleral Intraocular Lens Fixation Technique Using 27-Gauge Blunted Needles |
| Date of disclosure of the study information | 2021/05/27 |
| Last modified on | 2021/05/27 14:50:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intrascleral Intraocular Lens Fixation Technique Using 27-Gauge Blunted Needles
Acronym
Intrascleral Intraocular Lens Fixation Technique Using 27-Gauge Blunted Needles
Scientific Title
Intrascleral Intraocular Lens Fixation Technique Using 27-Gauge Blunted Needles
Scientific Title:Acronym
Intrascleral Intraocular Lens Fixation Technique Using 27-Gauge Blunted Needles
Region
| Japan |
Condition
Condition
IOL dislocation/fall, subluxated crystalline lens, aphakia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of intrascleral intraocular lens fixation with 27G blunt-ended needles
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Acuity, refractive error, IOL tilt, corneal endothelial cell density, complications
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intrascelral IOL fixation with 27G blunt-ended needles
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
IOL dislocation/subluxation, lens dislocation/subluxation, aphakia
Key exclusion criteria
microphthalmia, high myopia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennojiku
TEL
0667745111
masayuki@akimoto3.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennojiku
TEL
0667745111
Homepage URL
masayuki@akimoto3.com
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Red Cross Hospital
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
Osaka Red Cross Hospital
Address
5-30 Fudegasakicho, Tennojiku
Tel
0667745111
soumuka@osaka-med.jrc.or.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 | 05 | Month | 27 | 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
20
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 | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 12 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048780
