Treatment of recurrent pterygium with hyper dry human amniotic membrane(HD-AM)

JRCT ID: jRCTs042180103

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: recurrence pterygium
• Date of first enrollment: 25/04/2016
• Target sample size: 40
• Study type: Interventional

Intervention(s)

(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.

Outcome(s)

• Primary Outcome: It is the presence or absence of recurrence until 52 weeks after a surgical operation

Secondary Outcome

(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

Key inclusion & exclusion criteria

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

Include 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

Exclude criteria

1) Onset pterygium patient or pseudopterygium patients.
2)The patients whom a doctor judged safely for study period if it was difficult hospital visiting and to come home.
3)The patients who complicate eye infection with activity.
4)The patients who plan the enforcement of eye operations for evaluation eyes effective during 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 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) Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception.
9) The patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.

Related Information

• Primary Sponsor: Hayashi Atsushi
• Secondary ID(s): UMIN000021277