Exploratory clinical trial of artificial cornea Boston keratoprosthesis in eyes with refractory corneal opacity after unsuccessful corneal transplantation

Exploratory clinical trial of artificial cornea Boston keratoprosthesis in eyes with refractory corneal opacity after unsuccessful corneal transplantation - Exploratory clinical trial of artificial cornea Boston keratoprosthesis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007063

Enrollment

Registered

2012-01-13

Start date

2011-06-01

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 corneal opacity

Interventions

Transplantation of Boston KPro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Eyes after corneal transplant failure over twice in which unsuccessful corneal transplant is expected. 2) Best corrected visual acuity less than 0.05 and visual acuity in the contralateral eye is decreased. 3) Age of 20 years or more. 4) Patients giving informed consent with documents.

Exclusion criteria

Exclusion criteria: 1) End-stage glaucoma 2) Eyes with retinal detachment or optic disc atrophy. 3) Patients with auto-immune disease(pemphigoid, Stevens-Johnson syndrome, uveitis, Sjogren syndrome),after chemical burn, or severe inflammatory disease. 4) Eyes with incomplete blinking or insufficient tearing. 5) Patients who cannot receive frequent postoperative examination. 6) Pregnant women or women who are expected to be pregnant. 7) Breast-feeding women 8) Patients doctors did not think are appropriate for this study.

Design outcomes

Primary

Measure	Time frame
Efficacy: visual acuity Safety: Ratio of KPro survival	—

Secondary

Measure	Time frame
Complications, Adverse effects	—

Countries

Japan

Contacts

Public ContactTomohiko Usui

University of Tokyo Department of Ophthalmology

tomohiko-tky@umin.ac.jp03-5800-8660

Outcome results

None listed

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