UMIN-CTR Clinical Trial

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

corneal perforations, glaucoma, Recurrent pterygium

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Toyama University Hospital

Institute

Department

Personal name

Organization

Toyama University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Takaoka city hospital

Name of secondary funder(s)

Organization

Ethics Commitee, University of Toyama

Address

Sugitani2630, Toyama City

Tel

076-434-7145

Email

kanakada@med.u-toyama.ac.jp

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

富山大学附属病院（富山県）

Date of disclosure of the study information

2010

Year

01

Month

12

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2010

Year

01

Month

06

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=R000003620