Clinical trial NCT03069521: Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
Official title: Prospective, Feasibility Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cornel Edema
Lead sponsor: Eye-yon Medical
Sponsor class: INDUSTRY
First posted: 2017-03-03
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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®

Eligibility criteria: Inclusion Criteria:

1. Subject is over 40 years old
2. Subject with chronic corneal edema.
3. Subject with corneal thickness \>650 µm
4. Subject with visual acuity 6/30 or worse (equivalent ETDRS)
5. Subject with better visual acuity in the contralateral eye.
6. Pseudophakic subject (anterior or posterior) with stable IOL.
7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
2. Subject with history of ocular Herpes keratitis
3. Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
4. Subject with irregular posterior cornea (e.g. post PKP)
5. Subject who is suffering from infection of the cornea
6. Patients with band keratopathy and/or limbal stem cell deficiency.
7. Subject with clinical moderate to severe dry eye
8. Subject with phthisis or phthisis suspect
9. Subject with low ocular pressure ≤6 mmHg or higher than 25 mmHg.
10. Subject with aphakica
11. Subject with pseudophakodonesis
12. Subject with large iris defect which can compromise intraoperative AC stability.
13. Subjects after corneal refractive surgery.
14. Subject with glaucoma shunt (e.g. Ahmend valve)
15. Subject with neurotrophic corneal history
16. Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
17. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days

Primary outcomes:
measure: Treatment-related adverse events
timeFrame: 6 months following EndoArt implantaion
Secondary outcomes:
measure: Subjective corneal clarity
timeFrame: 12 months following EndoArt implantaion
measure: Pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: 12 months following EndoArt implantaion
measure: Measurement Best Corrected Distance Visual Acuity (BCDVA)
timeFrame: 12 months following EndoArt implantaion
measure: Corneal thickness
timeFrame: 12 months following EndoArt implantaion
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
city: Ashkelon
country: Israel
facility: Barzilai MC
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski Medical Center
city: Amsterdam
country: Netherlands
facility: AMC
city: Barcelona
country: Spain
facility: IMO - Institut de Microcirurgia Ocular
Study officials:
References: