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A Prospective-Retrospective Controlled Multicenter Clinical Trial on the Safety and Efficacy of One-Stage MIOK Keratoprosthesis Implantation in Patients with End-Stage Corneal Blindness

A Prospective-Retrospective Controlled Multicenter Clinical Trial on the Safety and Efficacy of One-Stage MIOK Keratoprosthesis Implantation in Patients with End-Stage Corneal Blindness

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096887
Enrollment
Unknown
Registered
2025-02-08
Start date
2025-02-15
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Corneal Blindness

Interventions

The MIOK Keratoprosthesis One-Stage Implantation Group:None
The MIOK Keratoprosthesis Two-Stage Implantation Group:None

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years. 2.Monocular or bilateral corneal blindness (according to the World Health Organization's criteria for blindness). 3.Multiple failures of conventional corneal transplant surgeries (the most common indication). 4.High-risk corneal transplant patients who are not suitable for conventional penetrating keratoplasty, such as those with corneal opacity accompanied by extensive neovascularization, aniridia, severe ocular burns, Stevens-Johnson syndrome, and severe dry eye syndrome.

Exclusion criteria

Exclusion criteria: 1.Absolute glaucoma. 2.End-stage optic nerve and retinal diseases. 3.Amblyopia due to form deprivation. 4.Severe systemic diseases or contraindications to surgery. 5.Pregnant or breastfeeding women. 6.Patients with unstable mental status or a history of psychiatric disorders who are unable to comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
KPro retention time;Best Corrected Visual Acuity;Postoperative complications;

Secondary

MeasureTime frame
Quality of Life Score;Surgical Cycle;

Countries

China

Contacts

Public ContactLiqiang Wang

Chinses PLA General Hospital

liqiangw301@163.com+86 139 1095 5301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026