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Recruitment status Completed
Unique ID issued by UMIN UMIN000006211
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Sapporo Tokushukai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007343


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