UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033229
Receipt No. R000037883
Scientific Title A prospective observational study of Bowman's layer transplantation for advanced keratoconus
Date of disclosure of the study information 2018/08/01
Last modified on 2019/07/02

* 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 A prospective observational study of Bowman's layer transplantation for advanced keratoconus
Acronym Bowman's layer transplantation for advanced keratoconus
Scientific Title A prospective observational study of Bowman's layer transplantation for advanced keratoconus
Scientific Title:Acronym Bowman's layer transplantation for advanced keratoconus
Region
Japan

Condition
Condition keratoconus, keratoectasia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This purpose of study is evaluation of the safety and efficacy of Bowman's layer transplantation (BLT). Examinations are scheduled one day, within a week, one week, 1 month, 3 months, 6 months, and 1 year after surgery, that include the topographic change, specular microsopy (endothelial cell density; ECD),and pachimetry(corneal thinckness) as well as standard ophthalmic examinations. After that, the follow-up will be scheduled every year for the purpose of evaluating the safety and efficacy of BLT.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes best spectacle-corrected visual acuity (BSCVA), and refraction (K-value) at 1 month, 3 months, 6 months, and 1 year postoperatively.
Key secondary outcomes best spectacle-corrected visual acuity (BSCVA), best contact lens-corrected visual acuity (BCLVA), AS-OCT-based corneal tomography measurements, endothelial cell density, refraction (K-value), and intraoperative, postoperative complications anterior and posterior HOAs, contact lens intolerance, and evaluation of the corneal structure using confocal microscopy at 1 month, 3 months, 6 months, and 1 year postoperatively.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 of advanced keratoconus or keratoectasia that are classified as stage 3 or 4 of Amsler-Krumeich classification, and are consistent with the conditions as shown belows;

Average K-value is under 50D, and K-max is over 60D.
The corneal thickness of apex is thinner than 400 um.
Pathiens with contact lens intolerance.
Key exclusion criteria Age is under 20 years old.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name TAKAHIKO
Middle name
Last name HAYASHI
Organization Yokohama Minami Kyosai Hospital
Division name Ophthalmology
Zip code 2360037
Address 1-21-1, Mutsuura-HigashiKanazawa-ku, Yokohama City, Kanagawa
TEL +81457872101
Email htakahiko-aikou@umin.ac.jp

Public contact
Name of contact person
1st name Takahiko
Middle name
Last name Hayashi
Organization Yokohama Minami Kyosai Hospital
Division name Cornea Center
Zip code 2360037
Address Kanazawa-ku
TEL +817038502167
Homepage URL
Email takamed@gmail.com

Sponsor
Institute Department of Ophthalmology, Yokohama Minami Kyosai Hospital
Institute
Department

Funding Source
Organization No funding
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 Yokohama Minami Kyosai Hospital
Address 1-21-1, Mutsuura-Higashi Kanazawa-ku, Yokohama
Tel +81457872101
Email htakahiko-aikou@umin.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
2018 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information No results.

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.