To evaluate the safety of the EndoArt* implanted in subjects suffering from corneal edema.
ID
Source
Brief title
Condition
- Eye disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* Corneal thickness
* Subjective corneal clarity
* Pain as assessed by a Visual Analogue Scale (VAS)
* Measurement Best Corrected Distance Visual Acuity (BCDVA)
Background summary
The posterior corneal surface is lined by the corneal endothelium, which
maintains corneal clarity. The endothelial cell layer functions passively as a
barrier to the influx of aqueous into the stroma and functions actively by
pumping excess fluid out of the stroma via pumps. Endothelial cell density
decreases at a rate of ~0.5% year; when endothelial cell density decreases to a
critical threshold, the cornea swells and eventually decompensates into bullous
keratopathy.
The EndoArt* device will serve as a water impermeable barrier and provide a
physical barrier to the passive movement of aqueous humor into the corneal
stroma. With the effect of evaporation from the corneal surface, it may
maintain corneal dehydration and clarity. The lack of endothelial pump in the
silicon layer may be compensated by the decreased permeability of the silicon
relative to the natural endothelium.
Study objective
To evaluate the safety of the EndoArt* implanted in subjects suffering from
corneal edema.
Study design
Prospective interventional study with 20 participants.
Intervention
EndoArt* implantation behind the cornea with or without endothelium removal.
Study burden and risks
Risks that may be associated with implantation of the EndoArt* are similar in
nature to those encountered with other Endothelial keratoplasty e.g. DSEK
(Descemet stripping endothelial keratoplasty) or DMEK (Descemet membrane
endothelial keratoplasty).
The following are possible risks the subject may experience from participation
in this research:
* Anterior or posterior synchiea
* Cornea abrasion, opacity
* Device Detachment and further surgical manipulation
* Worsening of corneal edema
* Cornea thinning and perforation
* IOP elevation due to procedure or steroids
* Infection
* Inflammation
* Cataract induction
* Retinal detachment
Golda Meir 5
Nes Ziona 7403649
IL
Golda Meir 5
Nes Ziona 7403649
IL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59331.018.16 |