UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006211 |
|---|---|
| Receipt number | R000007343 |
| Scientific Title | Change of corneal shape in cataract surgery using one-handed technique versus two-handed technique |
| Date of disclosure of the study information | 2011/08/23 |
| Last modified on | 2013/04/01 09:07:34 |
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Basic information
Public title
Change of corneal shape in cataract surgery using one-handed technique versus two-handed technique
Acronym
Change of corneal shape in cataract surgery using one-handed technique versus two-handed technique
Scientific Title
Change of corneal shape in cataract surgery using one-handed technique versus two-handed technique
Scientific Title:Acronym
Change of corneal shape in cataract surgery using one-handed technique versus two-handed technique
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare visual acuity and IOL power and operation time and corneal endothelial cell count and change of corneal shape including surgically induced astigmatism using Alpins method preoperatively and at six-month postoperative visits in cataract surgery between one-handed technique and two-handed technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
We compare change of corneal shape including surgically induced astigmatism using Alpins method between one-handed technique and two-handed technique.
Key secondary outcomes
We compare visual acuity and IOL power and operation time and corneal endothelial cell count between one-handed technique and two-handed technique.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with no ocular diseases other than cataract who are planned to have cataract surgery by one surgeon are selected for this study. In one eye, cataract surgery is performed during phacoemulsification and aspiration and intraocular lens 251 implantation by only 2.4mm incision. This surgical technique is one-handed technique.
Interventions/Control_2
Patients with no ocular diseases other than cataract who are planned to have cataract surgery by one surgeon are selected for this study. In the fellow eye, cataract surgery is performed during phacoemulsification and aspiration and intraocular lens implantation by 2.4mm incision and additional 0.9mm corneal side port. This surgical technique is two-handed technique.
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
1) No ocular diseases other than cataract
2) Cataract under Emery-Little classification Grade4
3) Undergoing cataract surgery in both eyes by the same surgeon
4) Under the description of the study to understand its significance, written consent is obtained from the patients themselves
5) Age of 20 years and over
Key exclusion criteria
1) Patients who are participated in another clinical study within 3 months of ophthalmology
2) Patients who are judged inappropriately for principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Kawahara |
Organization
Sapporo Tokushukai Hospital
Division name
Ophthalmology
Zip code
Address
1-1, Oyachihigashi 1chome, Atsubetsu-ku, Sapporo Hokkaido, 004-0041, JAPAN
TEL
011-890-1110
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kawahara |
Organization
Sapporo Tokushukai Hospital
Division name
Ophthalmology
Zip code
Address
1-1, Oyachihigashi 1chome, Atsubetsu-ku, Sapporo Hokkaido, 004-0041, JAPAN
TEL
011-890-1110
Homepage URL
Sponsor or person
Institute
Sapporo Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
医療法人徳洲会 札幌徳洲会病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 23 | 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
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
| 2011 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 22 | Day |
Last modified on
| 2013 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007343
