CorNeat KPro for Corneal Blindness

Recruiting at 5 trial locations

Overseen By Gilad Litvin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CorNeat Vision Ltd.

Must not be taking: Antibiotics, Anticoagulants

Disqualifiers: Retinal detachment, Glaucoma, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 1 day

40 Participants Needed

Trial Summary

What is the purpose of this trial?

A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation treatment, it must be interrupted for the surgical procedure.

What data supports the effectiveness of the CorNeat KPro treatment for corneal blindness?

Research on similar treatments, like the Boston Keratoprosthesis, shows that these devices can help restore vision in cases where traditional corneal transplants are unlikely to succeed. This suggests that the CorNeat KPro might also be effective in treating corneal blindness. ^{1 2 3 4 5}

How is the CorNeat KPro treatment different from other treatments for corneal blindness?

The CorNeat KPro is a novel keratoprosthesis (artificial cornea) designed to integrate with the eye tissue, offering a potential solution for patients who cannot benefit from traditional corneal transplants or other keratoprostheses due to lack of access or suitability. Unlike other options, it aims to be more accessible and less dependent on donor tissue, which is scarce in many regions. ^{1 3 6 7 8}

Eligibility Criteria

Adults aged 21-80 with legal blindness due to corneal diseases, who've had unsuccessful corneal transplants or aren't candidates for them. Must be able to follow study procedures and have adequate tear film and lid function. Women of childbearing age must use contraception.

Inclusion Criteria

I have been told I'm not a good candidate for corneal transplant due to conditions like herpetic keratitis or Steven Johnson Syndrome.

I am between 21 and 80 years old.

I can attend all visits and follow study rules.

Exclusion Criteria

My diabetes is not well-controlled, with an HbA1c over 8%.

I need continuous anticoagulation treatment that can't be stopped for surgery.

I currently have an infection and am taking antibiotics.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

The CorNeat KPro is implanted unilaterally in eligible subjects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical assessments and visual acuity measurements

24 months

15 visits (in-person) at 1 day, 1 week, 2 weeks, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 18, 21, and 24 months post-surgery

Treatment Details

Interventions

• CorNeat KPro

Trial Overview The trial is testing the CorNeat KPro, a device designed as a treatment for corneal blindness. This single-arm study involves multiple centers and doesn't compare against other treatments but measures safety and performance in eligible participants.

Participant Groups

Group I: CorNeat KPro Experimental Treatment 1 Intervention

Intraocular implantation of the CorNeat KPro

Who Is Running the Clinical Trial?

CorNeat Vision Ltd.

Lead Sponsor

Trials

4

Recruited

90+

Findings from Research

Keratoprosthesis (Kpro) surgery can provide a viable solution for patients with multiple graft failures, as demonstrated by a 30-year-old man who achieved stable vision 29 months post-surgery.

This case marks the introduction of Kpro surgery in Nepal, highlighting its potential to benefit patients with poor prognosis for traditional penetrating keratoplasty (PK).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keratoprosthesis, Dohlman type I device for a patient with repeated corneal graft failure. Bajracharya, L., Gurung, R., Tabin, G.[2012]

In a study of 43 eyes from 37 patients followed for an average of 39 months, the type I Boston keratoprosthesis (KPro) significantly improved vision, with 77% of eyes achieving a visual acuity of 20/200 or better after one year.

Despite its effectiveness in restoring vision, the procedure is associated with notable complications, including retroprosthetic membrane formation in 51% of cases and glaucoma progression in 47%, highlighting the need for careful monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary implantation of type I Boston keratoprosthesis in nonautoimmune corneal diseases. Chang, HY., Luo, ZK., Chodosh, J., et al.[2022]

The LVP keratoprosthesis (Kpro) demonstrated a high anatomical retention rate of 90.8% at 1 year and 76.6% at 3-5 years in a study of 58 eyes, indicating its effectiveness for patients with end-stage corneal blindness.

Postoperative visual acuity improved significantly, with 61.5% of eyes achieving 20/400 vision or better, showcasing the procedure's potential to restore sight in cases where traditional surgeries are not viable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LVP keratoprosthesis: anatomical and functional outcomes in bilateral end-stage corneal blindness. Basu, S., Nagpal, R., Serna-Ojeda, JC., et al.[2019]

In a study of 41 eyes from 37 patients who underwent Boston type 1 keratoprosthesis (KPro1) implantation, most patients experienced significant improvement in visual acuity, with the mean best corrected visual acuity improving from 2.05 to 1.16 logMAR after surgery.

Despite the overall positive visual outcomes, patients with a history of multiple ocular surgeries or systemic immune disorders faced higher risks of serious complications, including retroprosthetic membrane formation and infections, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-surgical visual outcome and complications in Boston type 1 keratoprosthesis. Muñoz-Gutierrez, G., Alvarez de Toledo, J., Barraquer, RI., et al.[2013]

The Boston KPro implantation in 30 patients with severe ocular trauma resulted in significant visual improvement, with postoperative visual acuity ranging from 20/20 to 20/80, demonstrating its efficacy in cases where standard corneal transplantation is not viable.

Anatomic success was achieved in 5 out of 5 mechanically traumatized eyes and 14 out of 17 chemically burned eyes, although the chemical burn group experienced a higher incidence of postoperative complications, particularly glaucoma progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Boston Keratoprosthesis in severe ocular trauma. Harissi-Dagher, M., Dohlman, CH.[2016]

Keratoprosthesis (Kpro) is a critical option for patients with bilateral end-stage corneal blindness, with a notable increase in procedures performed globally and in India over the last decade.

While the indications for Kpro have expanded and complications have decreased due to design improvements, successful outcomes require specialized setups and long-term follow-up care, highlighting the need for ophthalmologists to be well-informed about Kpro indications and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keratoprosthesis: Current global scenario and a broad Indian perspective. Iyer, G., Srinivasan, B., Agarwal, S., et al.[2018]

Keratoprosthesis (KPro) is a viable option for patients with end-stage ocular surface disease and multiple corneal transplant failures, particularly in developing countries where corneal transplants are less accessible.

Advancements in KPro technology and materials could lead to more effective, low-cost devices that require less frequent follow-up, potentially addressing the high rates of corneal blindness globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief review of Boston type-1 and osteo-odonto keratoprostheses. Avadhanam, VS., Liu, CS.[2015]

Boston KPro I and osteo-odonto-keratoprosthesis (OOKP) are effective solutions for corneal blindness, with improved outcomes due to advancements in postoperative care and complication management.

Efforts are underway to make Boston KPro I more affordable for patients in developing countries and to develop synthetic OOKP analogues, which will simplify the procedure and expand eligibility for patients with severely compromised ocular surfaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keratoprosthesis: Current Choices and Future Development. Zarei-Ghanavati, M., Liu, C.[2020]

References

1. Nepal pubmed.ncbi.nlm.nih.gov

Keratoprosthesis, Dohlman type I device for a patient with repeated corneal graft failure. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Primary implantation of type I Boston keratoprosthesis in nonautoimmune corneal diseases. [2022]

3. England pubmed.ncbi.nlm.nih.gov

LVP keratoprosthesis: anatomical and functional outcomes in bilateral end-stage corneal blindness. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

Post-surgical visual outcome and complications in Boston type 1 keratoprosthesis. [2013]

5. England pubmed.ncbi.nlm.nih.gov

The Boston Keratoprosthesis in severe ocular trauma. [2016]

6. India pubmed.ncbi.nlm.nih.gov

Keratoprosthesis: Current global scenario and a broad Indian perspective. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A brief review of Boston type-1 and osteo-odonto keratoprostheses. [2015]

8. China pubmed.ncbi.nlm.nih.gov

Keratoprosthesis: Current Choices and Future Development. [2020]