UMIN-CTR Clinical Trial

Basic information
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
Condition	recurrence pterygium
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Toyama University Hospital
Institute
Department

Funding Source
Organization	Toyama University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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）

Other administrative information
Date of disclosure of the study information	2016 Year 03 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	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
Other related information

Management information
Registered date	2016 Year 03 Month 01 Day
Last modified on	2020 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024541