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

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

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

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Other: Cryopreserved amniotic membrane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>subjects receiving cryopreserved amniotic membrane | Other: Cryopreserved amniotic membrane<br>* subjects will receive cryopreserved amniotic membrane<br>* Other names: ProKera Slim;|
| No Intervention: Control<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term efficacy in terms of corneal nerve regeneration | Assessed by corneal topography | Change from Baseline to 1 month | 
| Short-term efficacy in terms of ocular surface integrity | Assessed by in vivo confocal microscopy | Change from Baseline to 1 month | 
| Short-term efficacy in terms of corneal sensitivity |  | Change from Baseline to 1 month | 
| Short-term efficacy in terms of ocular clinical symptoms | Assessed by SPEED questionnaire, pain score, and dry eye workshop grading | Change from Baseline to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term efficacy in terms of corneal nerve regeneration | Assessed by corneal topography | Change from Baseline to 3 month | 
| Long-term efficacy in terms of ocular surface integrity | Assessed by in vivo confocal microscopy | Change from Baseline to 3 month | 
| Long-term efficacy in terms of corneal sensitivity |  | Change from Baseline to 3 month | 
| Long-term efficacy in terms of ocular clinical symptoms | Assessed by SPEED questionnaire, pain score, and dry eye workshop grading | Change from Baseline to 3 month |