UMIN-CTR Clinical Trial

Public title

Surgical reconstruction using the hyper dry human amniotic membrane : recurrence pterygium (proliferative tissue is limited to a thing more than the limbus.)

Acronym

Surgical reconstruction using the hyper dry human amniotic membrane

Scientific Title

Surgical reconstruction using the hyper dry human amniotic membrane : recurrence pterygium (proliferative tissue is limited to a thing more than the limbus.)

Scientific Title:Acronym

Surgical reconstruction using the hyper dry human amniotic membrane

Region

Japan

Condition

recurrence pterygium

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Confirm non-recessive efficacy and safety

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II

Primary outcomes

It is the presence or absence of recurrence until 52 weeks after a surgical operation

Key secondary outcomes

(1) Decimal visual acuity tests
(2) Ophthalmotonometry
(3) An examination for slit lamp microscopy and anterior segment of eyeball OCT
(4) Tensile speed of the pterygium tissue (measure it by anterior segment of eyeball OTC, and calculate it)
(5) Funduscopy
(6) A growth rate of the tissue

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

(1) After Benoxil ophthalmic solution dropping lotion in the eyes anesthesia, perform washing eyes, disinfection.
(2) After draping, put on ecarteur.
(3) Add Xylocaine anesthesia to pterygium body by subconjunctival injection under a microscope(We use general anesthesia for the hope of patients).
(4) Tear off corneal epithelium close against a front of the pterygium head.
(5) Ablate pterygium tissue using a golf sword to the limbus from the head.
(6) Ablate episcleral conjunctival epithelium and Tenon pouch enough and denude a sclera and excise pterygium.
(7) Douche it in a raw diet of approximately 300 ml after insertion attachment under 3-5min conjunctiva with the microsponge which we soaked with 0.04% MMC enough.
(8) The MMC becomes out of an accommodation to use it for a purpose to inhibit an activation (recurrence of the re-pterygium) of the subconjunctival proliferative tissue
(9) Match the stromal aspect of the hyper dry human desiccation cowl (HD cowl) with a sclerotic exposed surface and trim the part of the resection side with ophthalmology cusp sword.
(10) After put an HD cowl on the wounded surface, and arrival at sewing did an HD cowl to a sclera, repeat a conjunctiva stump on the top, and sew it up in a 1mm interior position; do.
(11) Have top and bottom right and left move an eyeball and check follows and add suturation, if necessary( We confirm after consciousness returned in the case of a general anesthesia).
(1) Is eye movement smooth?
(2) Is there not the pull companion whom it is impossible for conjunctiva to do?
(3) Does a suture not come off?
(12) Steroid subconjunctival injection or eye drops etc. is provided because of resolution and picks up a contact lens for treatment when corneal epithelium of the pupillary area greatly suffers a loss.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) age: The patients who relatively have good Patient 2) overall status of (at the agreement acquisition) 20 years old or older
3) The patients whom pathologic proliferative tissue invaded in recurrent pterygium across limbus.
4) The patients whom it is judged to be available for observation, the testing that conformed to a study enforcement plan and a survey

Key exclusion criteria

1) onset pterygium patient or pseudopterygium patients.
2)The patients whom a doctor judged safely for 2) study period if it was difficult hospital visiting and to come home.
3)The patients who complicate eye infection with 3) activity.
4)The patients who plan the enforcement of eye operations for evaluation eyes effective during 4) study period in (we assume the agreement acquisition study initiation).
5)one eyes are the patients of enucleation eyes or evisceration eyes.
6)For the group medicine of the planned drug (dropping lotion in the eyes anesthetic agent, fluorescein) to use during 6) study period, it is the patients with a history of the drug allergy.
7)The patients (saying that, however, the subjects who do not receive the study drug are possible) who participated in other studies or clinical studies within six months.
8)The patients whom a doctor judged as an object of this study in testing at pregnancy or 9 childbearing patients) agreement acquisition that we might be pregnant or hoped for pregnancy during study period or did not use appropriate contraception for if inadequate.

Target sample size

40

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Hayashi

Organization

University of Toyama

Division name

Department of Ophthalmology

Zip code

9300194

Address

Sugitani 2630, Toyama City, Toyama Prefecture

TEL

076-434-7363

Email

ahayashi@med.u-toyama.ac.jp

Name of contact person

1st name	Atsushi
Middle name
Last name	Hayashi

Organization

University of Toyama

Division name

Department of Ophthalmology

Zip code

9300194

Address

Sugitani 2630, Toyama City, Toyama Prefecture

TEL

+81-76-434-7363

Homepage URL

Email

ahayashi@med.u-toyama.ac.jp

Institute

Toyama University Hospital

Institute

Department

Personal name

Organization

Toyama University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Takaoka city hospital, Nagasaki University Hospital, Toho University Omori Medical Center, Matsue Red Cross Hospital, Kochi Medical School Hospital, University of Occupational and Environmental Health, Yamagata University Hospital, Akita University Hospital, University of Fukui Hospital, The University of Tokyo Hospital, Oita University Hospital, Hiroshima University Hospital, Shimane University Hospital

Name of secondary funder(s)

Organization

Ethics Committee, University of Toyama

Address

Sugitani 2630, Toyama City, Toyama Prefecture

Tel

076-434-2281

Email

rinri@adm.u-toyama.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

富山大学附属病院（富山県）、長崎大学病院（長崎県）、東邦大学医療センター大森病院（東京都）、秋田大学医学部付属病院（秋田県）、松江赤十字病院（島根県）、高知大学医学部附属病院（高知県）、山形大学医学部附属病院（山形県）、福井大学医学部附属病院（福井県）

Date of disclosure of the study information

2016

Year

03

Month

01

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

Open public recruiting

Date of protocol fixation

2015

Year

10

Month

26

Day

Date of IRB

2015

Year

10

Month

26

Day

Anticipated trial start date

2016

Year

04

Month

25

Day

Last follow-up date

2017

Year

04

Month

25

Day

Date of closure to data entry

2022

Year

03

Month

31

Day

Date trial data considered complete

2022

Year

04

Month

30

Day

Date analysis concluded

Other related information

Registered date

2016

Year

03

Month

01

Day

Last modified on

2020

Year

07

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024541