In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye

In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye

Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional treatment in patients with moderate to severe Dry Eye Disease (DED)

Inclusion Criteria:

• Subjects with moderate to severe DED (Grade 2-4 DEWS)
• Age range: 21 years and older.
• Both genders and all ethnic groups comparable with the local community.
• Subjects able to understand and willing to sign a written informed consent.
• Subjects able and willing to cooperate with investigational plan.
• Subjects able and willing to complete postoperative follow-up.

Exclusion Criteria:

• Symblepharon or lid abnormality preventing ProKera placement.
• Ocular infection within 14 days prior to study entry.
• Active ocular allergies.
• Previous ocular surgery or injury within 3 months before enrollment.
• Previous brain surgery, or Trigeminal nerve damage.
• Other conditions that may affect corneal nerves such as diabetes, thyroid disorders.
• Contact lens wearers.
• Pregnancy or subject expecting to be pregnant.
• Inability or unwillingness of subject to give written informed consent.
• Subjects with known intolerance to PK.
• Subjects use concomitant therapy that affects tear functions or ocular surface integrity.
• Subjects currently engaged in another clinical trial.