Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07344168
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects 30-85 years of age.
2. Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.
3. Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
4. 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.
5. Pseudophakia
6. Cornea WTW between 10-13 mm
7. IOP \<20 mmHg and IOP≥8 mmHg
8. 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).
9. 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.
10. Central general clarity grade ≥2 (See Table 14. Central general clarity grading)
11. Willing and able to understand and sign informed consent prior to any study-related procedure.
12. 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.
Exclusion Criteria:
1. No light perception or light perception.
2. Opaque scar in the visual axis that is indicated for PKP.
3. Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).
4. Current infection of the cornea.
5. Central Band keratopathy and/or limbal stem cell deficiency.
6. Diagnosis of: Sjogren's Syndrome, GVHD.
7. PUK (peripheral ulcerative keratitis)
8. Phthisis bulbi or subject is at high risk of developing phthisis (Hypothony).
9. History of corneal refractive surgery: LASIK, PRK, SMILE, Epi-keratoplasty (or any anterior lamellar keratoplasty, inlays) and Radial Keratotomy (RK).
10. Severe corneal distortion e.g.: keratoconus, pellucid marginal degeneration or keratoglobus (not relevant post PKP).
11. Subject with medically uncontrolled intra ocular pressure, which requires surgical intervention.
12. Aphakia.
13. Active inflammation, or active, recurrent, or Chronic Uveitis
14. Dislocation or partial dislocation of the IOL.
15. Have large iris defect (more than 90 degrees) which could compromise intraoperative air bubble formation, excluding inferior defect.
16. Severe ptosis (middle of pupil or covering the pupil entirely).
17. Subject receiving regular intravitreal injection.
18. History of persistent/ recurrent corneal erosion or persistent epithelial defect with difficulties in epithelial re-growth (erosion more than 2 months).
19. History of ocular herpetic keratitis
20. Current retinal detachments
21. Advanced optic nerve cupping (defined as a cup-disc ratio of 0.9 or greater).
22. Posterior segment masses or other acute significant posterior segment pathology (e.g., active age-related macular degeneration or chronic cystoid macular edema).
23. Afferent Pupillary Defect (APD)
24. Fellow eye CCT \< 500 µm
25. Any other acute ocular condition
26. Bilateral implantation of the EndoArt®
27. Posterior vitrectomy (anterior vitrectomy is allowed)
28. Subjects with mental impairment
29. Subject with history of spontaneous corneal perforations.
30. Pregnant or lactating women, or with childbirth plans during the clinical trial
31. Currently participating or have participated in an investigational study, other than this study, within the past 60 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT07344168
Study Brief:
Protocol Section:
NCT07344168