UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033229
Receipt number 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 2023/07/09 15:48:02

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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 or person

Institute

Department of Ophthalmology, Yokohama Minami Kyosai Hospital

Institute

Department

Personal name



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

0

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Lack of a number of candidates

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

Terminated

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

2025 Year 03 Month 31 Day

Date of closure to data entry

2025 Year 03 Month 31 Day

Date trial data considered complete

2025 Year 03 Month 31 Day

Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information

No result.


Management information

Registered date

2018 Year 07 Month 02 Day

Last modified on

2023 Year 07 Month 09 Day



Link to view the page

Value
https://center6.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