Health TrialsbyHealthPanel

Clinical Outcomes of the Gore Synthetic Cornea Device

ConditionCorneal Opacity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorW.L.Gore & Associates

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must meet all of the following criteria to be eligible to be consented for this study.

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.

Male or female patients ≥ 18 years old at the time of consent

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.)

Disqualifiers

Inability to provide written informed consent and comply with study assessments for the full duration of the study.

Age: < 18 years

Patients who are pregnant/nursing or planning to become pregnant during the study.

Corneal thickness measurement (epithelium to endothelium; central and mid-peripheral/ 3 to 5mm away from center at superior, inferior, nasal and temporal quadrants) in the study eye with any measurement less than 700um or more than 900um measured using US pachymetry. If one or more measurements cannot be obtained using US pachymetry, measurements using anterior segment OCT may be used

Trial design

Design model

Single group

Treatments tested in this trial

  • GORE Synthetic Cornea Device

    Device

    Treatment with GORE Synthetic Cornea Device

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: GORE Synthetic Cornea DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Effectiveness: Device retention

Number of study eyes with GORE Synthetic Cornea Device present

Time frame
Through 12 months
2

Primary Safety: Intraoperative Adverse Events

Number of subjects with procedure- and/or device-related adverse event during implant procedure

Time frame
At Initial Procedure
3

Primary Safety: Post-operative ophthalmic Adverse Events

Number of subjects with post-operative ophthalmic adverse event in the study eye

Time frame
Through 12 months
4

Primary Safety: Secondary surgical Intervention

Number of subjects requiring post-operative secondary surgical interventions (SSIs)

Time frame
Through 12 months

Secondary outcomes

1

Secondary Effectiveness: Improvement in Visual Acuity

Number of study eyes with improvement of two lines or more in Best Spectacle Corrected Distance Visual Actuity compared to pre-operative baseline

Time frame
Through 12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

W.L.Gore & Associates

Lead sponsor

Source ClinicalTrials.gov
Apply now