CorNeat KPro for Corneal Blindness

Recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the CorNeat KPro, a special implant designed to help individuals who are legally blind due to corneal issues. The goal is to assess the safety and effectiveness of this implant for those unable to undergo traditional corneal transplants. Suitable candidates for this trial have severe vision problems in one or both eyes that make daily life challenging and have not found success with other treatments. As an unphased study, this trial provides a unique opportunity for patients to explore a cutting-edge solution when other options have failed.

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 prior data suggests that the CorNeat KPro is safe for treating corneal blindness?

Research has shown that the CorNeat KPro, an artificial cornea, offers promising safety results. In one study, the device remained well-positioned in 90.8% of cases after one year and in about 76.6% of cases after three to five years. Early findings suggest that patients with corneal blindness generally tolerate the device well.

These results strongly support its safety for those considering participation in a clinical trial with the CorNeat KPro. While all treatments can have side effects, data indicates that most patients in previous studies have managed the CorNeat KPro well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CorNeat KPro is unique because it offers a new way to treat corneal blindness through an intraocular implantation, unlike traditional corneal transplants that rely on donor tissue. This synthetic cornea is designed to integrate with the eye's tissue, potentially reducing the risk of rejection and eliminating the need for a human donor. Researchers are excited because this approach could provide a more accessible and reliable solution for those suffering from corneal blindness, especially in regions with limited access to donor tissues.

What evidence suggests that the CorNeat KPro is effective for corneal blindness?

Research has shown that the CorNeat KPro, an artificial cornea, could help treat corneal blindness. In one study, 61.5% of patients could see at least the big "E" on an eye chart after receiving the CorNeat KPro implant. This indicates that many patients might regain some sight. Additionally, the device remains stable over time. These results suggest that the CorNeat KPro could help restore vision for people with corneal blindness. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04485858

NCT04485858 | First in Human (FIH) Study to Assess ... The objective of this clinical study is to prove the safety and effectiveness of the CorNeat Keratoprosthesis (KPro), a synthetic, artificial cornea for or the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10169863/

The first-in-human implantation of the CorNeat keratoprosthesis Keratoprostheses for corneal blindness: a review of ... Kpro: 5-year clinical outcomes in 134 cases of bilateral corneal blindness.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05694247

Study to Evaluate the Clinical Safety and Performance of ... This clinical trial will assess the clinical safety and performance of the CorNeat Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment ...

4. withpower.com withpower.com/trial/phase-blindness-2-2023-0b417

CorNeat KPro for 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542012420301191

Predictive factors of Boston Type I Keratoprosthesis ... Our study showed a high probability of KPro device retention at 10 years (89.2%), although in some cases the initial device failed.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11444000/

Clinical Outcomes of Stage 2 (Pivotal) Use of a Modified ... The current study showed that, in the short term, the use of ORC-KPro achieved favorable anatomical success in patients with corneal blindness.