Eligibility Criteria and Remote Consultation Guide for Vyznova (Neltependocel) Treatment
- 2 days ago
- 11 min read
Table of Contents
To determine whether Vyznova (neltependocel) treatment may be right for you, we need to carefully evaluate the current condition of your eye. Not every patient with bullous keratopathy is a candidate for Vyznova.
Our evaluation looks beyond the degree of corneal endothelial cell damage alone. We also assess your visual acuity, the overall condition of your cornea, other eye conditions such as glaucoma, the health of your retina and optic nerve, and your treatment history. Taken together, these factors allow us to identify the treatment best suited to you as an individual.
For international patients planning to travel to Japan, we recommend a Pre-arrival Remote Consultation. By reviewing your examination results in advance, our specialists can assess the following before your visit:
Your preliminary suitability for Vyznova treatment
The realistic visual outcomes you can expect
Safety considerations specific to your eye health and general medical condition
Whether alternative approaches, such as conventional corneal transplantation or prioritizing care for co-existing conditions, should be considered first
This process can help you avoid unnecessary travel and expense, and allows your care to proceed more smoothly once you arrive in Japan.
How Is Eligibility for Vyznova Determined?
Eligibility for Vyznova is never determined by a single test. In general, the following findings are important considerations in this decision:
Best-corrected visual acuity (BCVA) below approximately 0.7 (roughly 20/30)
Corneal endothelial cells that cannot be measured with specular microscopy
Increased corneal thickness due to corneal edema
Presence of corneal epithelial edema (bullae)
Even when these findings are present, Vyznova is not always the optimal treatment. For example, if the cornea has significant scarring or opacity, or if a retinal or optic nerve condition is the main cause of vision loss, we may recommend a different treatment approach instead.
For this reason, our corneal specialists examine the results of several tests together — described in detail below — to reach a comprehensive decision about whether Vyznova is right for you.
Examinations to Prepare for Your Remote Consultation
Your remote consultation will assess three areas.
1.Clinical History and Basic Information
We review your current condition, treatment history, visual acuity, intraocular pressure, and current medications, along with your general health and lifestyle, to determine whether treatment can be performed safely.
2.Anterior Segment Imaging
We closely examine your corneal endothelium, corneal swelling, and the condition of the corneal surface and inner layers. This is the single most important examination for determining whether Vyznova is likely to be effective.
3.Posterior Segment Imaging
We assess your retina and optic nerve for any conditions that may be contributing to your reduced vision. This examination is essential for predicting how much visual improvement can realistically be expected once your cornea becomes clear.
Below, we explain in detail what to prepare for each examination, and why it matters.
Clinical History and Basic Information
We need to understand the current condition of your eye, your medical history and general health.
Please prepare the following information before your online consultation.
What to Prepare
Eye History
Current symptoms and disease course
Previous diagnoses
History of previous eye surgery
Previous laser treatments or intraocular injections
Any active eye inflammation (e.g., uveitis, endophthalmitis, infectious keratitis)
Current eye drops and oral medications
Visual Function and Intraocular Pressure
Best-corrected visual acuity (BCVA) in both eyes
Intraocular pressure (IOP) in both eyes
If you use glaucoma eye drops, the medication name(s) and frequency of use
General Health
Any medical conditions currently under treatment (e.g., diabetes, hypertension, autoimmune disease, heart disease)
Current medications
Drug allergies
Any relevant history of surgery elsewhere in the body
Lifestyle Information
Occupation
Daily activities that require good vision (e.g., driving, reading, computer work, detailed manual tasks)
Whether someone will be available to assist or accompany you after surgery
Why This Information Is Needed
Disease Course and Treatment History
Bullous keratopathy can develop for many different reasons, including after cataract surgery, after glaucoma surgery, due to Fuchs endothelial corneal dystrophy, or as a result of trauma.
The underlying cause and your previous treatments influence whether Vyznova is appropriate, how much improvement can realistically be expected, and how your care should be managed after surgery. As a result, reviewing your disease course and surgical history in detail is crucial to determining the right treatment plan.
Active Eye Inflammation
Vyznova works by allowing transplanted corneal endothelial cells to engraft onto the inner surface of the cornea — a process that active inflammation inside the eye can disrupt, and that may itself worsen existing inflammation. For this reason, it is essential to confirm that no active intraocular inflammation is present before Vyznova is performed. If active inflammation is present, it must first be brought under control before Vyznova can be considered.
Best-Corrected Visual Acuity (BCVA)
Best-corrected visual acuity is your vision measured with the best possible correction from glasses or contact lenses. It helps us understand your current visual function and predict how much improvement you can expect after treatment.
In general, a best-corrected visual acuity below approximately 0.7 (roughly 20/30) is one of several benchmarks considered when evaluating candidacy for Vyznova.
Intraocular Pressure (IOP)
Intraocular pressure is an important indicator of overall eye health. For patients with coexisting glaucoma, we need to confirm that intraocular pressure is well controlled; if it is not, it may be necessary to prioritize glaucoma treatment before considering Vyznova.
Information about your current glaucoma eye drops is also important for planning your care before and after treatment.
General Health
Even for an eye treatment, your overall health plays an important role in ensuring that treatment can be performed safely. Diabetes can affect wound healing after surgery, and autoimmune or active inflammatory conditions may require careful timing and planning. If you are taking anticoagulant or antiplatelet medications, adjustments to your pre- and post-treatment management may be needed. If you have any drug allergies, we will review your medications carefully in advance to ensure your treatment is safe.
Occupation and Lifestyle
We also ask about your daily life and occupation so that we can set realistic, shared expectations for your visual outcome after treatment.
In addition, after Vyznova, patients are typically required to remain in a face-down position (looking downward) for approximately 3 hours immediately after surgery, so that the transplanted endothelial cells can adhere securely to the back surface of the cornea.
For this reason, we will also confirm:
Whether you have any neck or back conditions
Whether you are able to maintain a face-down position for approximately 3 hours
Whether assistance or support will be available to you if needed
Understanding your daily life and living environment helps us not only keep you safe during treatment, but also plan appropriately for your recovery and return to daily activities.
Anterior Segment Imaging (Corneal Examinations)
Vyznova is a cell-based treatment that targets the corneal endothelium. Therefore, a detailed evaluation of your current corneal condition is the single most important factor in determining whether Vyznova is an appropriate treatment for you.
Please prepare the following for your remote consultation.
What to Prepare
Slit-lamp photographs (without fluorescein staining)
Slit-lamp photographs (with fluorescein staining)
Corneal endothelial specular microscopy
Anterior segment OCT (corneal thickness map)
Anterior segment OCT (cross-sectional image)
If possible, please also provide the same information for your other (non-treated) eye. Comparing both eyes helps us understand your overall condition, identify the likely underlying cause, predict your visual prognosis, and plan treatments suited to you.
Why These Examinations Are Needed
Specular Microscopy
What This Examination Shows
This test evaluates the number of corneal endothelial cells (endothelial cell density, or ECD) and their shape. Because corneal endothelial cells cannot regenerate once significantly reduced, this is a critical examination for assessing the severity of bullous keratopathy.
Relevance to Vyznova
For Vyznova, one key benchmark is that the corneal endothelial cells cannot be observed or measured on specular microscopy.
When corneal swelling is severe, it can become impossible to obtain a clear image of the endothelial cells. This finding is itself considered an important sign of severe endothelial damage. Conversely, if endothelial cells can still be measured (imaged), the eye is generally not considered suitable for Vyznova.
Slit-Lamp Photography
What This Examination Shows
Slit-lamp examination allows us to evaluate:
Corneal clarity
Corneal edema (swelling)
Bullae (epithelial blistering)
Corneal opacity
Signs of infection or inflammation
Why Fluorescein Staining Is Used
Fluorescein, a dye applied to the surface of the eye, allows us to closely examine small defects or damage to the corneal epithelium. Epithelial damage can cause discomfort and increases the risk of infection, so it may require treatment before surgery. Epithelial edema (bullae) is also one of the key findings considered when evaluating candidacy for Vyznova.
Anterior Segment OCT (Corneal Thickness Map)
What This Examination Shows
Anterior segment OCT gives us a precise measurement of corneal thickness. When endothelial cell function declines, fluid accumulates within the cornea, causing it to become thicker than normal.
Relevance to Vyznova
In general, a cornea that is thicker than a healthy eye is one benchmark considered in this evaluation. We look not only at overall thickness, but also at which regions of the cornea show the most swelling, to help determine whether improvement can be expected with treatment.
Anterior Segment OCT (Cross-Sectional Imaging)
What This Examination Shows
Cross-sectional imaging allows a detailed review of:
The degree of corneal swelling
The condition of Descemet’s membrane
Any scarring within the cornea
The overall corneal structure
Relevance to Vyznova
Vyznova is designed to resolve corneal swelling. However, when long-standing disease has caused significant scarring or opacity within the corneal tissue itself, cell-based treatment alone may not achieve sufficient visual improvement. In such cases, another treatment — such as conventional corneal transplantation — may be more appropriate.
Therefore, this examination is a key step in determining whether the cornea is likely to respond to cell-based treatment.
Overall Evaluation from Anterior Segment Imaging
Based on these examinations, our corneal specialists evaluate:
Whether corneal endothelial damage has reached the stage where cell therapy is needed
Whether corneal edema is the primary cause of reduced vision
Whether cell-based treatment is likely to lead to improvement
Whether another treatment, such as conventional corneal transplantation, may be more suitable
Posterior Segment Imaging (Retina and Optic Nerve Examinations)
Vyznova treats the corneal endothelium, but vision does not depend on the cornea alone.
Even after your cornea becomes clear, visual improvement may be limited if your retina or optic nerve is also affected by disease. For this reason, our remote consultation reviews the retina and optic nerve in addition to the cornea.
These examinations are especially important if you have:
Glaucoma
Retinal disease, such as diabetic retinopathy
Macular disease, such as age-related macular degeneration
A history of retinal detachment, vitrectomy, or other retinal or vitreous surgery
What to Prepare
Wide-field fundus photography
Macular OCT
Ganglion Cell Complex (GCC) analysis
Visual field testing
Why These Examinations Are Needed
Wide-Field Fundus Photography
What This Examination Shows
Wide-field fundus photography provides an overview of the entire retina, allowing us to check for:
Diabetic retinopathy
Retinal vein occlusion
Retinal detachment
Age-related macular degeneration
Retinal degenerative disease
The results of any previous laser treatment or retinal surgery
We also review:
The condition of the optic disc
Changes associated with glaucoma
Abnormalities of the retinal blood vessels
Relevance to Vyznova
This examination helps confirm whether your reduced vision is caused primarily by corneal issues, or if an underlying retinal condition is also contributing to the vision loss.
Macular OCT
What This Examination Shows
Macular OCT provides a high-resolution view of the macula, the central part of the retina, allowing us to check for conditions such as:
Macular edema
Epiretinal membrane
Macular hole
Age-related macular degeneration
Macular atrophy
Structural abnormalities of the retina
Relevance to Vyznova
The macula is essential for tasks such as reading and recognizing faces. If the macula is damaged, central vision may have limited potential for improvement even after the cornea becomes clear.
Consequently, this scan helps us better predict how much visual improvement can realistically be expected after treatment. In some cases, severe corneal opacity may prevent this measurement from being obtained.
Ganglion Cell Complex (GCC) Analysis
What This Examination Shows
GCC analysis measures the thickness of the retinal ganglion cell layer, which carries visual information to the optic nerve. This is a common way to evaluate optic nerve damage caused by glaucoma.
Relevance to Vyznova
Once vision is lost due to advanced glaucoma, optic nerve function generally does not recover, which can limit improvement in vision and visual field even after the cornea becomes clear.
Reviewing the optic nerve with GCC analysis allows us to give you a more accurate picture of the visual outcome you can realistically expect from treatment.
Overall Evaluation from Posterior Segment Imaging
Based on these examinations, our corneal specialists evaluate:
Whether corneal endothelial disease is the primary cause of reduced vision
Whether the retina or optic nerve has any condition that may affect visual prognosis
How much visual improvement can realistically be expected from Vyznova
Whether additional treatment for retinal disease or glaucoma may be needed
Taking all of this information together, we are able to recommend the treatment plan best suited to you as an individual.
Who Is a Good Candidate for Vyznova?
Actually, Vyznova is not an appropriate treatment for every patient with bullous keratopathy. While the general benchmarks—such as reduced visual acuity, unmeasurable endothelial cells, and corneal swelling—are key indicators, these are guidelines only. The final decision is made by a corneal specialist based on a comprehensive evaluation of your overall eye health.
When Another Treatment May Be More Appropriate
Depending on your examination results, we may recommend a treatment other than Vyznova. Examples include:
When Corneal Clarity Is Unlikely to Be Restored
Significant scarring or opacity within the corneal stroma
Irreversible corneal damage resulting from long-standing corneal edema
In these cases, replacing the endothelial cells alone may not achieve meaningful visual improvement, and conventional corneal transplantation may be a more suitable option.
When the Cause of Reduced Vision Lies Outside the Cornea
Age-related macular degeneration
Diabetic retinopathy
Macular edema
Epiretinal membrane
Macular hole
Advanced glaucoma
Other optic nerve disease
If one of these conditions is the primary cause of your reduced vision, treating that condition first may be recommended.
Situations Requiring Careful Evaluation
In the following situations, additional careful evaluation is needed to ensure that Vyznova can be performed safely.
Glaucoma
Many patients with glaucoma are still able to undergo Vyznova. However, the surgical approach and treatment sequence require careful planning in situations such as:
Intraocular pressure that is not well controlled
Advanced glaucoma
Significant ocular structural changes following previous glaucoma surgery
Significant corneal opacity that limits evaluation of the back of the eye
Vision loss that is disproportionately severe relative to the corneal findings
In these cases, we may ask you to provide the results of a visual field test in advance, to help assess the extent of any visual impairment caused by glaucoma.
History of Multiple Prior Intraocular Surgeries
If you have had cataract surgery, vitrectomy, glaucoma surgery, or other intraocular procedures, the internal structure of your eye may differ from a typical eye. Using slit-lamp photographs and anterior segment OCT, we also review:
Position of the intraocular lens (IOL)
Condition of the iris
Presence of a filtering bleb or tube shunt
Anterior chamber depth
Presence of vitreous prolapse
This helps us determine whether cell-based treatment can be performed safely.
Coexisting Medical Conditions
If you have any of the following conditions, we will carefully consider the timing of treatment and your post-treatment care:
Autoimmune disease
Active infection
Poorly controlled diabetes
Any condition causing overall medical instability
Treatment may still be possible in these situations, but stabilizing your general health is sometimes prioritized first.
When Vyznova May Not Be Recommended
For safety reasons, Vyznova may not be performed — or another treatment may be prioritized — in situations such as:
Active intraocular inflammation or infection
Vision loss primarily caused by a condition other than corneal endothelial disease
Inability to maintain the required face-down position for approximately 3 hours after surgery
Difficulty attending follow-up visits and continuing post-treatment care
Cases in which your physician determines that safe treatment cannot be provided
About Your Final Treatment Plan
Our corneal specialists carefully review your eye condition and personal circumstances as a whole, and consider:
Whether Vyznova is a highly appropriate treatment for you
Whether conventional corneal transplantation may be preferable
Whether treatment for glaucoma or retinal disease should be addressed first
If Vyznova is not the right treatment for you, this does not mean that treatment is not possible. We are committed to recommending the treatment that is safest for you and offers the best possible chance of visual recovery.
Please note that your remote consultation provides a preliminary assessment based on the images, test results, and information you submit in advance. Whether Vyznova is ultimately appropriate for you, and your final treatment plan, can only be confirmed through an in-person examination — and any additional testing that may be required — after you arrive in Japan. A favorable impression during remote consultation does not guarantee that this treatment will ultimately be recommended or performed.
About the Author
Dr. Hideki Fukuoka, MD, PhD
Lecturer, Department of Ophthalmology, Kyoto Prefectural University of Medicine
