Chronic Cornel EdemaNCT03069521
Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
A study testing EndoArt® Artificial Endothelial Layer in people with Chronic Cornel Edema, run by Eye-yon Medical at 8 sites in 4 countries.
Trial summary
Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of 30 subjects suffering from corneal edema. Followed up for 12 months. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Cornel Edema
- What is being tested?
- EndoArt® Artificial Endothelial Layer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 22 Jun 2017to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is over 40 years old
- Subject with chronic corneal edema.
- Subject with corneal thickness >650 µm
- Subject with visual acuity 6/30 or worse (equivalent ETDRS)
- Subject with better visual acuity in the contralateral eye.
- Pseudophakic subject (anterior or posterior) with stable IOL.
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Who cannot join
- Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
- Subject with history of ocular Herpes keratitis
- Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
- Subject with irregular posterior cornea (e.g. post PKP)
- Subject who is suffering from infection of the cornea
- Patients with band keratopathy and/or limbal stem cell deficiency.
Show all 17Show fewer
- Subject with clinical moderate to severe dry eye
- Subject with phthisis or phthisis suspect
- Subject with low ocular pressure ≤6 mmHg or higher than 25 mmHg.
- Subject with aphakica
- Subject with pseudophakodonesis
- Subject with large iris defect which can compromise intraoperative AC stability.
- Subjects after corneal refractive surgery.
- Subject with glaucoma shunt (e.g. Ahmend valve)
- Subject with neurotrophic corneal history
- Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
- Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Israel5 sites
Barzilai MC
Ashkelon
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Assuta Medical Center
Tel Aviv
Tel Aviv Souraski Medical Center
Tel Aviv
Germany1 site
International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
Heidelberg
About this study
Official title: Prospective, Feasibility Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of 30 subjects suffering from corneal edema. Followed up for 12 months.
Read the detailed description
Title: Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of subjects suffering from corneal edema
Device: EndoArt® (Artificial Endothelial Layer)
Intended Use: The EndoArt® device is intended for use as an endothelial kearatoprosthesis in patients with chronic cornel edema
Study Design: Prospective open-label feasibility clinical study
Study Objectives: To evaluate the safety of the EndoArt® implanted in subjects suffering from corneal edema.
Study Hypothesis: Treatment with the EndoArt® is safe and may result in alleviating symptoms resulting from chronic corneal edema (corneal thickness).
Study population: Men and women suffering from a decrease in vision due to chronic corneal edema that meet the inclusion/exclusion criteria and provide written Informed Consent will enrolled in the study.
Enrollment: A total of up to 30 subjects will be enrolled.
Study Duration: Completion of active enrollment is anticipated to last approximately 18 months. The primary end point will be achieved when the final study subject has completed 6 month follow up. Subject will be followed up to 12 month.
Primary Safety Endpoint: The frequency and severity of all treatment-related adverse events, during and after implantation of the EndoArt® and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.
Secondary Efficacy Endpoints: Corneal thickness, Subjective corneal clarity, Pain as assessed by a Visual Analogue Scale (VAS) Measurement Best Corrected Distance Visual Acuity (BCDVA)
Study Treatment: Subjects will be implanted with the EndoArt®
- Conditions
- Chronic Cornel Edema
- Being tested
- EndoArt® Artificial Endothelial Layer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoArt® Artificial Endothelial LayerDevice
device is intended for use as an endothelial kearatoprosthesis
| Study group | Role | What they receive |
|---|---|---|
| EndoArt® | Other | EndoArt® Artificial Endothelial Layer Receives: Device: EndoArt® Artificial Endothelial Layer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events
frequency and severity of all treatment-related adverse events
Measured: 6 months following EndoArt implantaion
Secondary outcomes (4)
Subjective corneal clarity
corneal clarity will be graded by the investigator.
Scoring is as follow:
- 0- clear
- 1-iris details can be seen
- 2- iris details are obscure
- 3- can hardly see the pupil
- 4- pupil or iris details ca not be seen
Measured: 12 months following EndoArt implantaion
Pain as assessed by a Visual Analogue Scale (VAS)
VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end.
The subject marks on the line the point that he feels represents his perception of his current state.
Measured: 12 months following EndoArt implantaion
Measurement Best Corrected Distance Visual Acuity (BCDVA)
Visual acuity on the distance chart with best manifest correction for that distance
Measured: 12 months following EndoArt implantaion
Corneal thickness
Corneal thickness will be measured by anterior segment Optical Coherence Tomography (OCT).
Measured: 12 months following EndoArt implantaion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start22 Jun 2017
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cornel 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye-yon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069521
- Sponsor's protocol ID
- ECL00041
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2017
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Feasibility Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
- ClinicalTrials.gov ID
- NCT03069521
- Acronym / sponsor ID
- ECL00041
- Conditions
- Chronic Cornel Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Eye-yon MedicalIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 3 Mar 2017 (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.
Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of 30 subjects suffering from corneal edema. Followed up for 12 months.
Detailed description
Title: Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of subjects suffering from corneal edema
Device: EndoArt® (Artificial Endothelial Layer)
Intended Use: The EndoArt® device is intended for use as an endothelial kearatoprosthesis in patients with chronic cornel edema
Study Design: Prospective open-label feasibility clinical study
Study Objectives: To evaluate the safety of the EndoArt® implanted in subjects suffering from corneal edema.
Study Hypothesis: Treatment with the EndoArt® is safe and may result in alleviating symptoms resulting from chronic corneal edema (corneal thickness).
Study population: Men and women suffering from a decrease in vision due to chronic corneal edema that meet the inclusion/exclusion criteria and provide written Informed Consent will enrolled in the study.
Enrollment: A total of up to 30 subjects will be enrolled.
Study Duration: Completion of active enrollment is anticipated to last approximately 18 months. The primary end point will be achieved when the final study subject has completed 6 month follow up. Subject will be followed up to 12 month.
Primary Safety Endpoint: The frequency and severity of all treatment-related adverse events, during and after implantation of the EndoArt® and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.
Secondary Efficacy Endpoints: Corneal thickness, Subjective corneal clarity, Pain as assessed by a Visual Analogue Scale (VAS) Measurement Best Corrected Distance Visual Acuity (BCDVA)
Study Treatment: Subjects will be implanted with the EndoArt®
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoArt® | Other | Device: EndoArt® Artificial Endothelial LayerEndoArt® Artificial Endothelial Layer |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is over 40 years old
- Subject with chronic corneal edema.
- Subject with corneal thickness >650 µm
- Subject with visual acuity 6/30 or worse (equivalent ETDRS)
- Subject with better visual acuity in the contralateral eye.
Key exclusion criteria (17 listed)
- Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
- Subject with history of ocular Herpes keratitis
- Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
- Subject with irregular posterior cornea (e.g. post PKP)
- Subject who is suffering from infection of the cornea
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 |
|---|---|---|
| EndoArt® Artificial Endothelial Layerdevice is intended for use as an endothelial kearatoprosthesis | Device | EndoArt® |
Primary outcome
Treatment-related adverse events
Time frame: 6 months following EndoArt implantaion
frequency and severity of all treatment-related adverse events
4 secondary outcomes
Subjective corneal clarity
Time frame: 12 months following EndoArt implantaion
Pain as assessed by a Visual Analogue Scale (VAS)
Time frame: 12 months following EndoArt implantaion
Measurement Best Corrected Distance Visual Acuity (BCDVA)
Time frame: 12 months following EndoArt implantaion
Corneal thickness
Time frame: 12 months following EndoArt implantaion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoArt® Artificial Endothelial Layer in people with Chronic Cornel Edema, run by Eye-yon Medical at 8 sites in 4 countries.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel, Germany, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: 6 months following EndoArt implantaion). 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 16 Feb 2023.