RecruitingNot Applicable

Clinical Outcomes of the Gore Synthetic Cornea Device

Mexico10 participantsStarted 2024-08-19

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.)
✓. 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
✓. Best corrected distance visual acuity of worse than 20/400 in the study eye using Snellen chart
✓. Best corrected distance visual acuity of better than 20/200 in the fellow (non-study) eye using Snellen chart
✓. Pseudophakia status in the study eye with a stable posterior chamber intraocular lens (IOL) implant centered within the capsular bag or sulcus
✓. 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)

Exclusion criteria

✕. 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
✕. If applicable, prior corneal transplant \< 8 mm in diameter
✕. Aphakic or phakic status of the study eye
✕. Pseudophakic status of the study eye with anterior chamber IOL or unstable posterior chamber IOL, according to clinical history or UBM
✕. Evidence of tear film, ocular surface or lid abnormalities in the study eye

What they're measuring

Primary Effectiveness: Device retention

Timeframe: Through 12 months

Primary Safety: Intraoperative Adverse Events

Timeframe: At Initial Procedure

Primary Safety: Post-operative ophthalmic Adverse Events

Timeframe: Through 12 months

Primary Safety: Secondary surgical Intervention

Timeframe: Through 12 months

Trial details

NCT IDNCT06174376

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Anuraag Singh

410-506-7560 asingh@wlgore.com

View on ClinicalTrials.gov More Corneal Opacity trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.)
✓. 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
✓. Best corrected distance visual acuity of worse than 20/400 in the study eye using Snellen chart
✓. Best corrected distance visual acuity of better than 20/200 in the fellow (non-study) eye using Snellen chart
✓. Pseudophakia status in the study eye with a stable posterior chamber intraocular lens (IOL) implant centered within the capsular bag or sulcus
✓. 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)

Exclusion criteria

✕. 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
✕. If applicable, prior corneal transplant \< 8 mm in diameter
✕. Aphakic or phakic status of the study eye
✕. Pseudophakic status of the study eye with anterior chamber IOL or unstable posterior chamber IOL, according to clinical history or UBM
✕. Evidence of tear film, ocular surface or lid abnormalities in the study eye

What they're measuring

Primary Effectiveness: Device retention

Timeframe: Through 12 months

Primary Safety: Intraoperative Adverse Events

Timeframe: At Initial Procedure

Primary Safety: Post-operative ophthalmic Adverse Events

Timeframe: Through 12 months

Primary Safety: Secondary surgical Intervention

Timeframe: Through 12 months