In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
NCT ID: NCT02764814
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-07-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Treatment
subjects receiving cryopreserved amniotic membrane
Cryopreserved amniotic membrane
subjects will receive cryopreserved amniotic membrane
Control
no intervention
No interventions assigned to this group
Interventions
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Cryopreserved amniotic membrane
subjects will receive cryopreserved amniotic membrane
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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BioTissue Holdings, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas John, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas John Vision Institute
Locations
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Thomas John Vision Institute, P.C.
Tinley Park, Illinois, United States
Countries
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References
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John T, Tighe S, Sheha H, Hamrah P, Salem ZM, Cheng AMS, Wang MX, Rock ND. Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease. J Ophthalmol. 2017;2017:6404918. doi: 10.1155/2017/6404918. Epub 2017 Aug 15.
Other Identifiers
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P014-03
Identifier Type: -
Identifier Source: org_study_id