Our Summary

This research paper is about a clinical trial to test the effectiveness and safety of a new treatment for a condition called bullous keratopathy (BK). This condition affects the eyes and can cause blurry vision and discomfort. The treatment involves transplanting cultured human corneal endothelial cells (cHCEC) into the affected eyes.

In the clinical trials, 15 eyes with BK were treated in phase II and 12 eyes in phase III. The safety of the treatment was checked in all cases. The effectiveness was checked in 17 cases, excluding those that received lower doses in the phase II trial.

The main goal was for the transplanted cells to multiply and reach a density of 1000 cells per square millimeter, 24 weeks after the transplant. This goal was achieved in 94.1% of the treated eyes.

The second goal was for the thickness of the cornea to decrease to less than 630 micrometers without swelling, within the same time frame. This was achieved in 82.4% of the treated eyes.

The average decrease in corneal thickness was 187.4 micrometers. In addition, all treated eyes showed an improvement in best-corrected visual acuity (clarity of vision) from before to 24 weeks after the transplant.

By 24 weeks after the transplant, 88.9% of the patients had experienced side effects. However, these were mostly local (at the site of treatment), mild, and temporary.

The study concludes that the cHCEC product used is effective in treating BK. It helps to restore the layer of cells at the back of the cornea, reduce corneal thickness, and improve vision.

FAQs

  1. What is the primary endpoint of the corneal endothelial cell transplant therapy?
  2. How effective was the cHCEC product in improving visual acuity and reducing corneal thickness in patients with bullous keratopathy?
  3. What were the common adverse events experienced by patients post-transplant?

Doctor’s Tip

A helpful tip a doctor might tell a patient about corneal transplant is to follow all post-operative care instructions carefully, including using prescribed eye drops, avoiding rubbing or touching the eye, and attending follow-up appointments to monitor healing and check for any signs of complications. It is also important to protect the eye from injury or infection during the recovery period.

Suitable For

Patients with bullous keratopathy (BK) are typically recommended for corneal transplant therapy. This includes individuals with corneal endothelial dysfunction leading to corneal edema, decreased visual acuity, and corneal thickness greater than 630 µm. These patients may benefit from a cultured human corneal endothelial cell (cHCEC) product, which has been shown to effectively restore corneal endothelial cell density, reduce corneal thickness, and improve visual acuity in clinical trials. Patients with BK who have not responded to other treatment options may be candidates for this innovative therapy.

Timeline

  • Before corneal transplant: The patient experiences symptoms of bullous keratopathy, such as blurred vision, eye pain, and sensitivity to light. The patient undergoes a series of examinations and tests to determine if a corneal transplant is necessary, including visual acuity tests, corneal thickness measurements, and endothelial cell density assessments.

  • Corneal transplant procedure: The patient undergoes a corneal transplant surgery where the diseased cornea is removed and replaced with a donor cornea. In this study, cultured human corneal endothelial cells (cHCEC) were used in the transplant procedure. The primary endpoint of the study was to achieve a corneal endothelial cell density of 1000 cells/mm2 or more at 24 weeks post-transplant.

  • After corneal transplant: The patient is monitored closely post-operatively for any signs of rejection or complications. In this study, 94.1% of the eyes achieved the primary endpoint of corneal endothelial cell density of 1000 cells/mm2 or more at 24 weeks post-transplant. Additionally, 82.4% of the eyes met the secondary endpoint of reduction in corneal thickness to less than 630 µm without corneal epithelial edema within the same time frame. Visual acuity also improved in all eyes post-transplant.

  • Adverse events: By 24 weeks post-transplant, 88.9% of the patients experienced adverse events, which were mostly local, mild, and transient. The cHCEC product used in the study was found to be safe and effective in reconstituting the corneal endothelial layer with high cellular density, restoring corneal thickness, and improving visual acuity.

What to Ask Your Doctor

  1. What is the success rate of corneal transplant surgery for my condition?
  2. How long is the recovery process after corneal transplant surgery?
  3. What are the potential risks and complications associated with corneal transplant surgery?
  4. Will I need to take immunosuppressant medications after the surgery?
  5. How often will I need to follow up with you after the surgery?
  6. Are there any specific lifestyle changes I should make after the surgery to ensure the best outcome?
  7. How soon after the surgery will I notice improvements in my vision?
  8. Are there any restrictions on physical activities or eye care routines after the surgery?
  9. What are the alternative treatment options available for my condition?
  10. Can you provide me with more information about the cHCEC transplant therapy and how it compares to traditional corneal transplant surgery?

Reference

Authors: Ueno M, Imai K, Tomioka Y, Horiguchi G, Kameda T, Teramukai S, Tsujikawa A, Inatomi T, Sotozono C, Kinoshita S. Journal: Jpn J Ophthalmol. 2024 Nov;68(6):660-668. doi: 10.1007/s10384-024-01123-w. Epub 2024 Oct 2. PMID: 39356386