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The clinical application study of keratoprosthesis for end-stage corneal blindness patients

The clinical application study of keratoprosthesis for end-stage corneal blindness

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030908
Enrollment
Unknown
Registered
2020-03-17
Start date
2015-05-01
Completion date
Unknown
Last updated
2020-03-23

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

Conditions

corneal blindness

Interventions

Case series:Keratoprosthesis implantation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This clinical trial aims at patients with severe corneal blindness in both eyes, end-stage corneal blindness patients who cannot achieve long-term rehabilitation of corneal blindness through any other corneal transplantation surgery, including the cases with severe corneal vascularization, end-stage dry eyes, severe eyelid conjunctival sac abnormality or eyelid atresia, multiple corneal transplantation failures, etc., and cases who give up corneal transplantation after they have been confirmed by corneal experts in other medical institutions. At the same time, the following basic conditions should be met: 1. 18 years of age or older; 2. Retina and optic nerve structure and function with visual potential rehabilitation; 3. The primary diseases and inflammation of the eyes are basically stable, and there is no active infection (especially chemical, thermal burns and autoimmune diseases) ); 4. Normal IOP measurement by hands or IOP basically under control without medication in cases with glaucoma; 5. Make regular follow-up visits successfully as required; 6. Understanding related conditions of keratoprosthesis including indications and surgical risks; 7. Ability to follow postoperative requirements and instructions strictly (medication, follow-up, etc.).

Exclusion criteria

Exclusion criteria: 1. who have severe systemic diseases and couldn't tolerate surgery; 2. those who can restore eyesight by corneal transplantation; 3. those whose IOP couldn't be under control or be stable without medication; 4. the original disease is unstable such as chemical burns, thermal burns and other inflammations; 5. poor function of the retina or optic nerve (no potential to restore vision); 6. those who do not understand the risk of keratoprosthesis surgery, can not regularly follow up and take the medication as required.

Design outcomes

Primary

MeasureTime frame
the rate of relief from blindness;

Secondary

MeasureTime frame
the rate of keratoprosthesis in eye;best corrected visual acuity;

Countries

China

Contacts

Public ContactYifei Huang

First Medical Center, PLA General Hospital

301yk@sina.com+86 18600574957

Outcome results

None listed

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