Corneal EdemaNCT07344168
EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study
A study testing The EndoArt® (Corneal Artificial Endothelial layer) in people with Corneal Edema, run by Eye-yon Medical.
Trial summary
The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Corneal Edema
- What is being tested?
- The EndoArt® (Corneal Artificial Endothelial layer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 30-85 years of age.
- Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.
- Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
- CCT of 650-1200 μm, not including DSAEK thickness.
- In cases where the treated eye has undergone PKP, or if the corneal thickness of the contralateral eye cannot be measured (e.g., monocular patient, or if the contralateral eye has corneal edema or a history of PKP), the CCT of the study eye must be between 700-1200 μm.
- Pseudophakia
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- Cornea WTW between 10-13 mm
- IOP <20 mmHg and IOP≥8 mmHg
- BCVA of the study eye equal or worse than 0.50 LogMAR and up to 2.40 LogMAR (Hand motion is between 2.20-2.40 LogMAR).
- Must have better visual acuity in the contralateral eye, which must be at least 0.20 LogMAR better than the treated eye and have a visual acuity of at least 1.00 LogMAR.
- Central general clarity grade ≥2 (See Table 14. Central general clarity grading)
- Willing and able to understand and sign informed consent prior to any study-related procedure.
- Willing and able to follow study instructions (e.g., to lay on one's back for at least 4 hours post op.), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits/assessments for the duration of the study.
Who cannot join
- No light perception or light perception.
- Opaque scar in the visual axis that is indicated for PKP.
- Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).
- Current infection of the cornea.
- Central Band keratopathy and/or limbal stem cell deficiency.
- Diagnosis of: Sjogren's Syndrome, GVHD.
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- PUK (peripheral ulcerative keratitis)
- Phthisis bulbi or subject is at high risk of developing phthisis (Hypothony).
- History of corneal refractive surgery: LASIK, PRK, SMILE, Epi-keratoplasty (or any anterior lamellar keratoplasty, inlays) and Radial Keratotomy (RK).
- Severe corneal distortion e.g.: keratoconus, pellucid marginal degeneration or keratoglobus (not relevant post PKP).
- Subject with medically uncontrolled intra ocular pressure, which requires surgical intervention.
- Aphakia.
- Active inflammation, or active, recurrent, or Chronic Uveitis
- Dislocation or partial dislocation of the IOL.
- Have large iris defect (more than 90 degrees) which could compromise intraoperative air bubble formation, excluding inferior defect.
- Severe ptosis (middle of pupil or covering the pupil entirely).
- Subject receiving regular intravitreal injection.
- History of persistent/ recurrent corneal erosion or persistent epithelial defect with difficulties in epithelial re-growth (erosion more than 2 months).
- History of ocular herpetic keratitis
- Current retinal detachments
- Advanced optic nerve cupping (defined as a cup-disc ratio of 0.9 or greater).
- Posterior segment masses or other acute significant posterior segment pathology (e.g., active age-related macular degeneration or chronic cystoid macular edema).
- Afferent Pupillary Defect (APD)
- Fellow eye CCT < 500 µm
- Any other acute ocular condition
- Bilateral implantation of the EndoArt®
- Posterior vitrectomy (anterior vitrectomy is allowed)
- Subjects with mental impairment
- Subject with history of spontaneous corneal perforations.
- Pregnant or lactating women, or with childbirth plans during the clinical trial
- Currently participating or have participated in an investigational study, other than this study, within the past 60 days.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt® in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK/PK) Have Failed, and Who Are Not Reasonable Candidates for Any Form of Corneal Transplant, Including Penetrating Keratoplasty
The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.
The EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.
Read the detailed description
The study is a prospective, multi-center, open-label, single arm pivotal clinical investigation. The objective is to evaluate the safety and effectiveness of EndoArt® implantation in subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) procedures have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.
Safety will be assessed by evaluating the rate of any device related SAE occurred through the 12-month follow-up period.
The primary effectiveness endpoint is the proportion of subjects achieving an improvement in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or an improvement to at least 1.30 LogMAR for subjects with baseline BCVA equal or worse than 1.30 LogMAR, at 12 months postoperatively.
Subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty will be the study target population.
Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will include a total of 123 surgically treated subjects. This clinical investigation will be conducted in a maximum of fifteen (20) clinical sites in the USA.
- Conditions
- Corneal Edema
- Being tested
- The EndoArt® (Corneal Artificial Endothelial layer)
- Keywords
- Corneal edema, Chronic corneal edema, Artificial Endothelial layer, EndoArt, Failed keratoplasty, Human tissue corneal transplantation failure, Failed DSEK, Failed DMEK
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EndoArt® (Corneal Artificial Endothelial layer)Device
Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK
| Study group | Role | What they receive |
|---|---|---|
| EndoArt® Artificial Endothelial Layer | Experimental | Implantation of the EndoArt (Artificial Endothelial Layer) Receives: Device: The EndoArt® (Corneal Artificial Endothelial layer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of any device related SAE
SAEs may include, but are not limited to, e.g., secondary surgical intervention, severe infectious keratitis requiring hospitalization, and corneal perforation
Measured: 12 months
Improvement in visual acuity as measured by BCVA
The proportion of subjects achieving a change in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or a visual acuity of 1.30 LogMAR or better at 12 months postoperatively for subjects with baseline BCVA of 1.30 LogMAR or worse
Measured: 12 months
Secondary outcomes (8)
All AE rate
Rate of each AE
Measured: 12 months
BCVA Success rate
BCVA Success rate of bad Vision Population (Baseline BCVA ≥ 1.30 LogMAR)
Measured: 12 months
CCT
Change in central corneal thickness as measured by OCT from baseline to 12 months
Measured: 12 months
Change in manifest refraction
The change in manifest refraction
Measured: 12 months
Corneal clarity
Change in central general clarity grading score (using a scale of 0-normal to 4-severe)
Measured: 12 months
Distribution of BCVA change
BCVA change
Measured: 12 months
Distribution of BCVA outcomes (using FrACT10)
BCVA outcomes
Measured: 12 months
BCVA Success rate
BCVA Success rate of good Vision Population (Baseline BCVA < 1.30 LogMAR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye-yon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344168
- Sponsor's protocol ID
- CLI-E053
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt® in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK/PK) Have Failed, and Who Are Not Reasonable Candidates for Any Form of Corneal Transplant, Including Penetrating Keratoplasty
- ClinicalTrials.gov ID
- NCT07344168
- Acronym / sponsor ID
- CLI-E053
- Conditions
- Corneal Edema
- Keywords
- Corneal edema, Chronic corneal edema, Artificial Endothelial layer, EndoArt, Failed keratoplasty, Human tissue corneal transplantation failure, Failed DSEK, Failed DMEK
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Eye-yon MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.
The EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.
Detailed description
The study is a prospective, multi-center, open-label, single arm pivotal clinical investigation. The objective is to evaluate the safety and effectiveness of EndoArt® implantation in subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) procedures have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.
Safety will be assessed by evaluating the rate of any device related SAE occurred through the 12-month follow-up period.
The primary effectiveness endpoint is the proportion of subjects achieving an improvement in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or an improvement to at least 1.30 LogMAR for subjects with baseline BCVA equal or worse than 1.30 LogMAR, at 12 months postoperatively.
Subjects with chronic corneal edema, in whom multiple prior keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty will be the study target population.
Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will include a total of 123 surgically treated subjects. This clinical investigation will be conducted in a maximum of fifteen (20) clinical sites in the USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoArt® Artificial Endothelial Layer | Experimental | Device: The EndoArt® (Corneal Artificial Endothelial layer)Implantation of the EndoArt (Artificial Endothelial Layer) |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects 30-85 years of age.
- Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.
- Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
- CCT of 650-1200 μm, not including DSAEK thickness.
- Pseudophakia
Key exclusion criteria (31 listed)
- No light perception or light perception.
- Opaque scar in the visual axis that is indicated for PKP.
- Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).
- Current infection of the cornea.
- Central Band keratopathy and/or limbal stem cell deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The EndoArt® (Corneal Artificial Endothelial layer)Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK | Device | EndoArt® Artificial Endothelial Layer |
Primary outcome
The rate of any device related SAE
Time frame: 12 months
SAEs may include, but are not limited to, e.g., secondary surgical intervention, severe infectious keratitis requiring hospitalization, and corneal perforation
Improvement in visual acuity as measured by BCVA
Time frame: 12 months
The proportion of subjects achieving a change in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or a visual acuity of 1.30 LogMAR or better at 12 months postoperatively for subjects with baseline BCVA of 1.30 LogMAR or worse
8 secondary outcomes
All AE rate
Time frame: 12 months
BCVA Success rate
Time frame: 12 months
CCT
Time frame: 12 months
Change in manifest refraction
Time frame: 12 months
Corneal clarity
Time frame: 12 months
Distribution of BCVA change
Time frame: 12 months
Distribution of BCVA outcomes (using FrACT10)
Time frame: 12 months
BCVA Success rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing The EndoArt® (Corneal Artificial Endothelial layer) in people with Corneal Edema, run by Eye-yon Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Limor Kuznits (+972-73-7803607, limor@eye-yon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of any device related SAE (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.