UMIN-CTR Clinical Trial

Public title

Clinical Trial of corneal crosslinking for keratoconus and keratoectasia

Acronym

Clinical Trial of corneal crosslinking for keratoconus and keratoectasia

Scientific Title

Clinical Trial of corneal crosslinking for keratoconus and keratoectasia

Scientific Title:Acronym

Clinical Trial of corneal crosslinking for keratoconus and keratoectasia

Region

Japan

Condition

Keratoconus, Keratoectasia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate safety and efficacy of corneal crosslinking for keratoconus and keratoectasia

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Uncorrected and best corrected visual acuity, maximum corneal refractive power in corneal topography

Key secondary outcomes

corneal thickness measured by anterior segment OCT

Study type

Interventional

Basic design

Factorial

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

corneal crosslinking with removal of corneal epithelium

Interventions/Control_2

corneal crosslinking without removal of corneal epithlium

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

14

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Those whose age at obtaining informed consent meet following criteria
Keratoconus: 14 years old and more
Keratoectasia: 20 years old and more
2) Those whose diagnosis by corneal topography is keratoconus, keratoconus suspect or keratoectasia
3) The thinnest corneal thickness is over 400 micron meter. In the case that corneal thickness is less than 400 micron meter, it is necessary of more than 400 micro meter of corneal thickness during surgery after adding hypotonic riboflavin solution.
In case without removal of corneal epithelium, the criteria is more than 380 micro meter of corneal thickness.
4) Progressive keratoconus or keratoectasia meeting any of the following criteria;
-the maximum corneal refractive power (Kmax) increases of more than 1 diopter
-manifest astigmatism increases of more than 1 diopter
-manifest spherical equivalent increases more than 1 diopter
-base curve of hard contact lenses decreases of more than 0.1mm
5) In case of keratoconus, no history of acute hydropes
6) In case of keratoectasia, those who have a history of refractive surgery such as LASIK
7) Patients whose voluntary consent document was obtained after receiving enough explanation about this study
8) Outpatient

Key exclusion criteria

1)Those undergoing drug therapy for such as glaucoma, more than moderate dry eye or allergy
2)those with ocular disease such as uveitis
3)those with systemic disease that can affect wound healing, such as diabetes
4)Those without obvious progression of the disease for a year before sugery
5)Those with corneal melting disase
6)Those without lens
7)Those with intraocular lens which have no protective function against ultraviolet
8)Woman who are or might be pregnant
9)Lactating woman
10) Those who received other investigational clinical trials within 3 months before the beginning of this study
11) Patients who are judged to be unsuitable as a subject by investigator

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Tomohiko Usui

Organization

the University of Tokyo Hospital

Division name

Department of Ophthalmology

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

tomohiko-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomohiko Usui

Organization

the University of Tokyo Hospital

Division name

Department of Ophthalmology

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

tomohiko-tky@umin.ac.jp

Institute

the University of Tokyo Hospital

Institute

Department

Personal name

Organization

Non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

11

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

06

Month

27

Day

Date of IRB

2011

Year

10

Month

20

Day

Anticipated trial start date

2012

Year

06

Month

27

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

21

Day

Last modified on

2019

Year

05

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011016