Prospective, Feasibility study to evaluate the safety of the EndoArt* for Treatment of Subjects Suffering from Corneal Edema
- Conditions
- 'Corneal edema''Corneal swelling'10015919
- Registration Number
- NL-OMON53003
- Lead Sponsor
- EyeYon Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The frequency and severity of all treatment-related adverse events, during and<br /><br>after implantation of the EndoArt* and throughout the 6 month follow-up period.<br /><br>Adverse events will be assessed on a continuous basis from the procedure<br /><br>through the study completion at 6 months. Related adverse events include:<br /><br>corneal perforation, melting, uncontrolled inflammation, severe infection. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Corneal thickness<br /><br>* Subjective corneal clarity<br /><br>* Pain as assessed by a Visual Analogue Scale (VAS)<br /><br>* Measurement Best Corrected Distance Visual Acuity (BCDVA)</p><br>