Corneal Opacity
Conditions
Keywords
Artificial Corneal transplantation, corneal opacity, corneal blindness
Brief summary
Study objective is to evaluate the initial safety and effectiveness of the GORE Synthetic Cornea Device in the treatment of loss of corneal clarity in patients who are candidates for corneal transplantation
Detailed description
This is a prospective, single-arm, open-label, multi-center early feasibility clinical study designed to evaluate the clinical outcomes of the GORE Synthetic Cornea Device in the treatment of loss of corneal clarity in patients who are candidates for corneal transplantation. Following procedure, clinical follow up will be scheduled over the course of the study duration (12 months).
Interventions
DEVICEGORE Synthetic Cornea Device
Treatment with GORE Synthetic Cornea Device
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients must meet all of the following criteria to be eligible to be consented for this study. 1. Patient must be able to comprehend the study requirements and provide written informed consent. Patients must be willing to follow study instructions, agree to comply with all study procedures , and able to return for all scheduled follow-up examinations for 12 months postoperatively (the study duration). The follow-up exams may be extended up to 60 months post operatively if the patient consents to the extension. 2. Male or female patients ≥ 18 years old at the time of consent 3. Physical condition suitable for undergoing surgery, as evidenced by medical history and physical examination provided by a licensed medical provider (primary care physician, nurse practitioner, internal medicine physician etc.) 4. Currently with an opaque cornea (as determined by the investigator) with or without a prior history of failed donor corneal transplantation \[penetrating keratoplasty (PK) or endothelial keratoplasty (EK)\] and loss of corneal clarity 5. Best corrected distance visual acuity of worse than 20/400 in the study eye using Snellen chart 6. Best corrected distance visual acuity of better than 20/200 in the fellow (non-study) eye using Snellen chart 7. Pseudophakia status in the study eye with a stable posterior chamber intraocular lens (IOL) implant centered within the capsular bag or sulcus 8. Corneal thickness measurement in study eye (epithelium to endothelium; central and mid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal and temporal quadrants) with each measurement between 700um - 900um, measured using ultrasound (US) pachymetry. If one or more measurements cannot be obtained using US pachymetry, measurements using anterior segment optical coherence tomography (OCT) may be used (with the measurement being between 700-900um) 9. If applicable, prior corneal transplant ≥ 8 mm in diameter 10. Adequate lid function and normal ocular surface and tear film parameters for implant of the study device, as determined by the investigator. Key
Exclusion criteria
* Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness: Device retention | Through 12 months | Number of study eyes with GORE Synthetic Cornea Device present |
| Primary Safety: Intraoperative Adverse Events | At Initial Procedure | Number of subjects with procedure- and/or device-related adverse event during implant procedure |
| Primary Safety: Post-operative ophthalmic Adverse Events | Through 12 months | Number of subjects with post-operative ophthalmic adverse event in the study eye |
| Primary Safety: Secondary surgical Intervention | Through 12 months | Number of subjects requiring post-operative secondary surgical interventions (SSIs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness: Improvement in Visual Acuity | Through 12 month | Number of study eyes with improvement of two lines or more in Best Spectacle Corrected Distance Visual Actuity compared to pre-operative baseline |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORArturo Ramirez Miranda, MD
Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana I.A. P.
PRINCIPAL_INVESTIGATORValeria Sanchez Huerta, MD
Asociación para Evitar la Ceguera en México, I.A.P
Outcome results
None listed