Treatment of ocular surface with HD-AM

JRCT ID: jRCTs042190030

Registered date:27/05/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Refractory eyes surface disease
• Date of first enrollment: 27/05/2019
• Target sample size: 52
• Study type: Interventional

Intervention(s)

<Pterygium / including Scleral malacia / Conjunctival tumor (Intraconjunctival hyperplasia)>
*In the case of scleromalacia, we omit following 3) - 8)
(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 micro sponge which we soaked with 0.04% MMC enough. 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.
(8) 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.
(9) 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.
(10) Have top and bottom rig ht 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?
(11)If necessary, 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.

<Corneal perforation / Conjunctival perforation>
(1)Benoxil instillation anesthesia, Xylocaine anesthesia wash their eyes, and they disinfect it after (they may put it under general anesthesia for the hope of subjects).
(2)After draping, we put on ecarteur.
(3)After drying around leakage department in cellulose sponge under a microscope, and having trimmed human drying amnion (HD-AM), suturation glues it together in the perforation part.
(4)We check follows,
1)If HD-AM slips off from the perforation department, we do it again.
2)If there is leakage from the HD-AM periphery, we do it again.
(5)If necessary, we dribble antibacterial eye drops and ride a contact lens for the treatment.

< Glaucoma bleb leak/Glaucoma bleb scarring>
(1)Benoxil instillation anesthesia, Xylocaine anesthesia wash their eyes, and they disinfect it after (they may put it under general anesthesia for the hope of subjects)
(2)After draping, we put on ecarteur
(3)After drying around leakage department in cellulose sponge under a microscope, and having trimmed human drying amnion (HD-AM), select bellow.
1:Adhesion or suture on the bleb surface.
2:stuffed into the breve.
3:suture in the breve.
(4)If necessary, the HD-AM is packed when bleb reconstruction is required.
(5) Benoxil uses it, and, in the case of leakage treatment, check follows.
1) If HD-AM slips off from the perforation department, we do it again.
2) If there is leakage from the HD-AM patch periphery, we do it again.
(6)If necessary, we dribble antibacterial eye drops and ride a contact lens for the treatment.

< Corneal / conjunctival epithelial defect (including Corneal scar, induced by the Corneal transplantation) >
(1)Benoxil instillation anesthesia, Xylocaine anesthesia wash their eyes, and they disinfect it after (they may put it under general anesthesia for the hope of subjects)
(2)After draping, we put on ecarteur
(3)Tenon capsule lower anesthesia is provided and we resect cicatricial tissue of a cornea and the bulbar conjunctiva under a microscope widely and denude parenchyma of cornea and sclera
(4)Put stromal masks of the HD-AM together to an eyeball side and trim a shape with ophthalmology cusp sword
(5)We put HD-AM the eyeball side and sew up HD amnion on the sclera
(6)We check follows,
1) If there is the pull companion whom it is impossible for conjunctiva to do, we sew it up again
2) If a suture comes off, we add suturation
(7)If necessary, steroid subconjunctival injection is provided because of resolution

< Symblepharon adhesion (including Stevens-Johnson Syndrome, Pemphigoid of the eye, Thermochemical trauma scar, heavy Scarring keratoconjunctival disease)>
(1)Benoxil instillation anesthesia, Xylocaine anesthesia wash their eyes, and they disinfect it after (they may put it under general anesthesia for the hope of subjects)
(2)After draping, we put on ecarteur
(3)After removing tumors under a microscope, and having trimmed human drying amnion (HD-AM), suturation glues HD-AM together in the removal part (lesion) and coats it
(4)We check follows,
1) If HD-AM deviates from a lesion, we do it again
(5)If necessary, we dribble antibacterial eye drops and ride a contact lens for the treatment

Outcome(s)

Primary Outcome

1)Pterygium:Recurrence (scleromalacia:Presence by the examination with slit lamp, a conjunctiva tumor:Reproduction of epithelium)
2)corneal perforation:Choke
3)Glaucoma bleb leakage:Aqueous humor leakage
4)A cornea, conjunctival epithelium deficiency:Reproduction of epithelium
5)Symblepharon (conjunctival sac reconstruction):Presence or absence of symblepharon by the examination with slit lamp

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)1:Pterygium/including Scleral malacia/Conjunctival tumor(Intraconjunctival hyperplasia), 2:Corneal perforation/Conjunctival perforation, 3:Glaucoma bleb leak/Glaucoma bleb scarring, 4:Corneal/conjunctival epithelial defect (including Corneal scar, induced by the Corneal transplantation), 5:Symblepharon adhesion (including Stevens-Johnson Syndrome, Pemphigoid of the eye, Thermochemical trauma scar, heavy Scarring keratoconjunctival disease)
2) more than 20 years-old
3)The patients with relatively good general condition
4) The patients whom it is judged to be available for observation, the testing that conformed to a study enforcement plan and a survey.

Exclude criteria

1)The patients whom a doctor judg ed safely for study period if it was difficult hospital visiting and to come home.
2)The patients who complicate eye infection with activity.
3)The patients who plan the enforcement of eye operations for evaluation eyes effective during study period in (we assume the ag reement acquisition study initiation).
4)one eyes are the patients of enucleation eyes or evisceration eyes.
5)For the g roup medicine of the planned drug(dropping lotion in the eyes anesthetic ag ent, fluorescein) to use during study period, it is the patients with a history of the drug allergy.
6)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.
7) Preg nancy or the childbearing patients who may be preg nant or hope for preg nancy during study period or do not use appropriate contraception.
8) Patients who can be entried Advanced Medical B (jRCTs 042180103).
9)The patients who were judg ed to be inadequate as an object of this study in testing at agreement acquisition by doctor.

Related Information

• Primary Sponsor: Hayashi Atsushi