Corneal Tissue Inlay for Keratoconus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cornea and Laser Eye Institute

Disqualifiers: Pregnancy, Corneal disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Corneal Tissue Inlay for Keratoconus?

Research on similar treatments, like the annular intracorneal inlay combined with corneal cross-linking, and Bowman layer inlay transplantation, shows positive long-term outcomes for keratoconus. Additionally, studies on corneal stromal regeneration therapies, including stem cell and collagen-based approaches, indicate potential effectiveness in treating advanced keratoconus. ^{1 2 3 4 5}

Is the corneal tissue inlay safe for humans?

Some studies on similar treatments, like intracorneal ring segments, show that while they are generally safe, rare complications can occur, such as tissue perforation and unusual cell accumulation. More research is needed to fully understand the long-term safety of these procedures. ^{6 7 8 9 10}

How does the corneal tissue inlay treatment for keratoconus differ from other treatments?

The corneal tissue inlay treatment for keratoconus is unique because it involves placing a thin layer of donor corneal tissue into the patient's cornea to increase its thickness and stabilize the condition. This approach is different from other treatments like corneal cross-linking or intracorneal rings, as it directly augments the corneal structure, potentially allowing for future surface treatments to improve vision. ^{1 2 5 11 12}

Research Team

Peter Hersh, MD

Principal Investigator

Cornea and Laser Eye Institute

Eligibility Criteria

This trial is for adults with moderate to severe keratoconus, a condition that affects the cornea of the eye. Participants must be willing to follow instructions and attend follow-up visits. Women cannot be pregnant to join. People with allergies to trial materials, mild or suspected keratoconus, history of slow corneal healing, other significant eye conditions, or recent participation in other trials are excluded.

Exclusion Criteria

I am not pregnant.

I have had an eye condition before that could cause future problems.

My eye has had slow healing from a previous injury or surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a corneal tissue inlay to treat keratoconus

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular visits as per study protocol

Treatment Details

Interventions

• Corneal tissue inlay

Trial Overview The study tests placing preserved corneal tissue into the affected cornea of patients with keratoconus. The goal is to improve thickness and stability of the cornea and correct its shape for better vision.

Participant Groups

Group I: Corneal tissue inlay Experimental Treatment 1 Intervention

The treated cornea will be implanted with a thin disc of preserved corneal tissue

Who Is Running the Clinical Trial?

Cornea and Laser Eye Institute

Lead Sponsor

Trials

10

Recruited

1,100+

References

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

Seven-year follow-up of a novel 360-degree implant (annular intracorneal inlay) plus accelerated corneal cross-linking: A case study. [2023]

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

Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Visual, refractive and topographic outcomes of progressive thickness intrastromal corneal ring segments for keratoconic eyes. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Corneal collagen cross-linking followed by phacoemulsification with IOL implantation for progressive keratoconus associated with high myopia and cataract. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Corneal Stromal Regeneration: A Review of Human Clinical Studies in Keratoconus Treatment. [2021]

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

Histopathologic findings in two cases with history of intrastromal corneal ring segments insertion. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Allogenic corneal tissue transplantation in substitution for extruded intracorneal rings: A case series. [2020]

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

Intracorneal ring segment implantation for the management of keratoconus: safety and efficacy. [2022]

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

Histopathological findings after intracorneal ring segment implantation in keratoconic human corneas. [2022]

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

Corneal collagen cross-linking before Ferrara intrastromal corneal ring implantation for the treatment of progressive keratoconus. [2022]

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

Bowman-stromal inlay using an intraocular lens injector for management of keratoconus. [2023]

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

Correcting keratoconus with intracorneal rings. [2022]