In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/23/2016 |
| Start Date: | July 2015 |
| End Date: | November 2016 |
Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional
treatment in patients with moderate to severe Dry Eye Disease (DED)
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.
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