UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020256
Receipt number R000023387
Scientific Title Effectiveness of Corneal stromal transplantation in corneal stromal thining
Date of disclosure of the study information 2016/01/05
Last modified on 2016/01/14 12:09:44

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Basic information

Public title

Effectiveness of Corneal stromal transplantation in corneal stromal thining

Acronym

Effectiveness of Corneal stromal transplantation

Scientific Title

Effectiveness of Corneal stromal transplantation in corneal stromal thining

Scientific Title:Acronym

Effectiveness of Corneal stromal transplantation

Region

Japan


Condition

Condition

Corneal stromal thinning

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate corneal stromal transplantation (donor stroma prepred by femto-seconfd laser) in case with corneal stromal thinning including keratoconus

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Visual Acuity at 1 and 3 months after surgery
2. Intraocular pressure at 1 and 3 months after surgery
3. Topography and Corneal thickness at 1 and 3 months after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver Other

Interventions/Control_1

Donor stromal cornea prepared by femto-second laser was transplanted into recipient cornea lammelar cut also by femto-seconf laser.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Visual acuity with hard contact lenses < 0.6 or visual acuity with glasses <0.4
2. 250 < the thinnest corneal thickness < 400 micro m
3.Patients decided as necessary of corneal transplantation by attending doctor.

Key exclusion criteria

1. Alkari corneal burn, Stevens-Johnson Syndrome, ocular pemphygoid
2. Severe corneal opacity and/or scar formation
3. Abnormal margin of eye lid inclugding tumor
4. After refractive surgery including LASIK

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Kawakita

Organization

Minami aoyama eye clinic

Division name

Ophthalmology

Zip code


Address

3-3-11, Kita-aoyama, Minato, Tokyo

TEL

03-5772-1451

Email

kawatetsu@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Kawakita

Organization

minami aoyama eye clinic

Division name

Ophthalmology

Zip code


Address

3-3-11, Kita-aoyama, Minato, Tokyo

TEL

03-5772-1451

Homepage URL


Email

kawatetsu@gmail.com


Sponsor or person

Institute

Minami aoyama eye clinic

Institute

Department

Personal name



Funding Source

Organization

Self Funding

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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 05 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

Preinitiation

Date of protocol fixation

2015 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 17 Day

Last modified on

2016 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023387


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name