UMIN-CTR Clinical Trial

Basic information
Public title	The surgical repair of refractory ocular surface diseases using amniotic membrane.
Acronym	The surgical repair of refractory ocular surface diseases using amniotic membrane.
Scientific Title	The surgical repair of refractory ocular surface diseases using amniotic membrane.
Scientific Title:Acronym	The surgical repair of refractory ocular surface diseases using amniotic membrane.
Region	Japan

Condition
Condition	corneal perforations, glaucoma, Recurrent pterygium
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of a novel dried-amniotic membrane in cases with 1)corneal perforations, 2)leaking filtering glaucoma bleb and 3)revisions, 4)Recurrent pterygium of glaucoma filtering bleb.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1)visual acuity,2)intraocular pressures,3)Slit-lamp examinations including fluorescein dye staining,4)Ocular examinations by Anterior segment OCT
Key secondary outcomes	Evaluation of corneal thickness by corneal pachymeter.

Base
Study type	Interventional

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

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	The patients with corneal perforations receive a single layer patch of the dried amniotic membrane using tissue adhesive in the minor procedure room under topical anesthesia with 2% lidocaine. The dried amniotic membrane is trimmed to the appropriate size and shape before application. A tissue adhesive, 2-octyl cyanoacrylate is applied to the epithelial side of the the amniotic membrane. After drying the perforated site with a cellulpse sponge, the dried amniotic membrane with tissue adhesive is placed over the lesion using forceps. After topical instillation of 0.5 % levofloxacin, a hydrogel contact lens is installed as a bandage.
Interventions/Control_2	2% lidocaine hydrochloride is instilled in the left eye. The dried amniotic membrane is cut to an appropriate size with scissors and tissue adhesive is applied to the amniotic epithelial side of the dried membrane. After drying the leakage site with a cellulose sponge, dried amniotic membrane with tissue adhesive is placed over the leakage site using forceps. A drop of 0.5% topical levofloxacin is instilled and the dried membrane is hydrated. A hydrogel contact lens is placed on the cornea as a bandage.
Interventions/Control_3	Revisions of glaucoma filtering bleb. After local anesthesia, the dried amniotic membrane is cut to an appropriate size with scissors and the dried amniotic membrane is inserted through the conjunctival incision underneath the conjunctival bleb. The amniotic membrane is secured with 10-0 nylon. The surface is covered with conjunctival tissues.
Interventions/Control_4	(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. (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. 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 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_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	Cause unknown corneal perforation Traumatic corneal perforation Corneal perforation related to collagen diseases Bleb leaks after glaucoma surgery Bleb failure due to unsuccessful glaucoma surgery <recurrence pterygium> The patients who had a diagnosis of the refractory eyes surface disease that at least one eye (target eyes) packed all the following criteria. In addition, the case same with an eye of the good few visions a binocular a few vision does oculus dexter with an efficacy evaluation eye when both eyes pack all the following criteria.Assume a fellow eye a control. 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	Acute obvious ocular infectious signs are excluded. Exp. 1) Acute phase of bacterial, mycotic, or viral corneal ulcers 2) Acute phase of infectious bleb <recurrence pterygium> 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	250

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	930-0194
Address	Sugitani 2630, Toyama City, Toyama Prefecture
TEL	+81-76-434-7363
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	930-0194
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	JAPAN

Other related organizations
Co-sponsor	Takaoka city hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Commitee, University of Toyama
Address	Sugitani2630, Toyama City
Tel	076-434-7145
Email	kanakada@med.u-toyama.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	188,Rinhen21-45
Org. issuing International ID_1	Ethical Review Board on University of Toyama
Study ID_2	Rin20-45,Rinhen20-50
Org. issuing International ID_2	Ethical Review Board on University of Toyama
IND to MHLW

Institutions
Institutions	富山大学附属病院（富山県）

Other administrative information
Date of disclosure of the study information	2010 Year 01 Month 12 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2004 Year 04 Month 16 Day
Date of IRB	2004 Year 04 Month 16 Day
Anticipated trial start date	2004 Year 04 Month 17 Day
Last follow-up date	2004 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 01 Month 06 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=R000003620