A prospective observational study of Bowman's layer transplantation for advanced keratoconus

A prospective observational study of Bowman's layer transplantation for advanced keratoconus - Bowman's layer transplantation for advanced keratoconus

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033229

Enrollment

Registered

2018-08-01

Start date

2018-08-01

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

keratoconus, keratoectasia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of advanced keratoconus or keratoectasia that are classified as stage 3 or 4 of Amsler-Krumeich classification, and are consistent with the conditions as shown belows; Average K-value is under 50D, and K-max is over 60D. The corneal thickness of apex is thinner than 400 um. Pathiens with contact lens intolerance.

Exclusion criteria

Exclusion criteria: Age is under 20 years old.

Design outcomes

Primary

Measure	Time frame
best spectacle-corrected visual acuity (BSCVA), and refraction (K-value) at 1 month, 3 months, 6 months, and 1 year postoperatively.	—

Secondary

Measure	Time frame
best spectacle-corrected visual acuity (BSCVA), best contact lens-corrected visual acuity (BCLVA), AS-OCT-based corneal tomography measurements, endothelial cell density, refraction (K-value), and intraoperative, postoperative complications anterior and posterior HOAs, contact lens intolerance, and evaluation of the corneal structure using confocal microscopy at 1 month, 3 months, 6 months, and 1 year postoperatively.	—

Measure

Time frame

best spectacle-corrected visual acuity (BSCVA), best contact lens-corrected visual acuity (BCLVA), AS-OCT-based corneal tomography measurements, endothelial cell density, refraction (K-value), and intraoperative, postoperative complications anterior and posterior HOAs, contact lens intolerance, and evaluation of the corneal structure using confocal microscopy at 1 month, 3 months, 6 months, and 1 year postoperatively.

—

Countries

Japan

Contacts

Public ContactTakahiko Hayashi

Yokohama Minami Kyosai Hospital Cornea Center

takamed@gmail.com+817038502167

Outcome results