UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040437 |
|---|---|
| Receipt number | R000046148 |
| Scientific Title | 27-Gauge trocar-assisted sutureless intraocular lens fixation. |
| Date of disclosure of the study information | 2020/05/18 |
| Last modified on | 2020/05/18 18:29:47 |
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Basic information
Public title
27-Gauge trocar-assisted sutureless intraocular lens fixation.
Acronym
27-Gauge trocar-assisted sutureless intraocular lens fixation.
Scientific Title
27-Gauge trocar-assisted sutureless intraocular lens fixation.
Scientific Title:Acronym
27-Gauge trocar-assisted sutureless intraocular lens fixation.
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 report a novel technique for sutureless intrascleral fixation of the intraocular lens (IOL) using retinal forceps with a 27-gauge trocar.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main outcome measures were visual acuity, corneal endothelial cell density, IOL tilt, decentration, predicted error of refraction and complications.
Follow up periodo is 1month.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A 27gauge trocar formed 3mm scleral tunnels positioned at 4 and 10 oclock, 2 mm from the corneal limbus. We used a 3piece IOL haptic grasped by a 27gauge retinal forceps and pulled from the 27gauge trocar. The IOL was fixed by making a flange.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients were given diagnosis of IOL dislocation/fall, subluxated crystalline lens and aphakia.
Key exclusion criteria
The study exclusion criteria were hazy cornea or corneal scarring, aniridia, macular scarring, glaucoma and postoperative follow-up for less than 1 month.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Jujo |
Organization
St. Marianna University School of Medicine
Division name
Ophthalmology
Zip code
2168514
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
0449778111
t2jujo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Jujo |
Organization
St. Marianna University School of Medicine
Division name
Ophthalmology
Zip code
2168514
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
0449778111
Homepage URL
t2jujo@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
0449778111
t2jujo@marianna-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
| 2020 | Year | 05 | Month | 18 | 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
19
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
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 10 | 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 | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046148
