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

TissueTech

Status

Completed

Conditions

Dry Eye Disease

Treatments

Other: Cryopreserved amniotic membrane

Study type

Interventional

Funder types

Industry

Identifiers

NCT02764814

P014-03

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.