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Optimizing the Ocular Surface Prior to Cataract Surgery

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ClinicalTrials.gov Identifier: NCT02766907
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : March 5, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Tissue Tech Inc.

Study Description
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Brief Summary:
Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.

Condition or disease Intervention/treatment Phase
Corneal Dystrophy, Epithelial Basement Membrane Device: cryopreserved amniotic membrane Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimizing the Ocular Surface Prior to Cataract Surgery
Study Start Date : March 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Study
prospective arm receiving cryopreserved amniotic membrane
 Device: cryopreserved amniotic membrane
placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
Other Name: Prokera Slim (PKS)
No Intervention: Control
Retrospective review of debridement without cryopreserved amniotic membrane


Outcome Measures
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Primary Outcome Measures :
  1. Change in Intraocular Lens Calculation [ Time Frame: Change from Baseline to 1 month ]
    Assessed by corneal topography

  2. Change in Intraocular Lens Power Calculation [ Time Frame: Change from Baseline to 1 month ]
    Assessed using biometry and calculated using Holladay I formula


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with significant EBMD that are contemplating cataract surgery.
  2. Age range: 50 years and older.
  3. Both Genders and all ethnic groups comparable with the local community.
  4. Subjects able to understand and willing to sign a written informed consent.
  5. Subjects able and willing to cooperate with the investigational plan.
  6. Subjects able and willing to complete postoperative follow-up.

Exclusion Criteria:

  1. Subjects with known intolerance to PKS or known allergy to its preservative media.
  2. Subjects with symblepharon or lid abnormality preventing PKS placement.
  3. Ocular infection within 14 days prior to study entry.
  4. Previous ocular surgery or injury within 3 months before enrollment.
  5. Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
  6. Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766907


Locations
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United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Tissue Tech Inc.
Investigators
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Principal Investigator: Elizabeth Yeu, MD Virginia Eye Consultants
More Information
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Responsible Party: Tissue Tech Inc.
ClinicalTrials.gov Identifier: NCT02766907    
Other Study ID Numbers: P015-2
First Posted: May 10, 2016    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cataract
Corneal Dystrophies, Hereditary
Lens Diseases
Eye Diseases
 Corneal Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn