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Treatment of ocular surface with HD-AM

The surgical repair of refractory ocular surface diseases using Hyper dry human amniotic membrane (HD-AM) - SROHD-AM

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042190030
Enrollment
52
Registered
2019-05-27
Start date
2022-04-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory eyes surface disease

Interventions

*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 ecar
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 m

Sponsors

Hayashi Atsushi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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)The patients who were judg ed to be inadequate as an object of this study in testing at agreement acquisition by doctor.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
(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

Contacts

Public ContactAkio Miyakoshi

University of Toyama

akio3854@med.u-toyama.ac.jp+81-76-434-7363

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026