Back to resultsOptimizing the Ocular Surface Prior to Cataract Surgery
Primary Purpose
Corneal Dystrophy, Epithelial Basement Membrane
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryopreserved amniotic membrane
Sponsored by
About this trial
This is an interventional other trial for Corneal Dystrophy, Epithelial Basement Membrane
Eligibility Criteria
Inclusion Criteria:
- Subjects with significant EBMD that are contemplating cataract surgery.
- Age range: 50 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 the investigational plan.
- Subjects able and willing to complete postoperative follow-up.
Exclusion Criteria:
- Subjects with known intolerance to PKS or known allergy to its preservative media.
- Subjects with symblepharon or lid abnormality preventing PKS placement.
- Ocular infection within 14 days prior to study entry.
- Previous ocular surgery or injury within 3 months before enrollment.
- Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
- Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
Sites / Locations
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study
Control
Arm Description
prospective arm receiving cryopreserved amniotic membrane
Retrospective review of debridement without cryopreserved amniotic membrane
Outcomes
Primary Outcome Measures
Change in Intraocular Lens Calculation
Assessed by corneal topography
Change in Intraocular Lens Power Calculation
Assessed using biometry and calculated using Holladay I formula
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02766907
Brief Title
Optimizing the Ocular Surface Prior to Cataract Surgery
Official Title
Optimizing the Ocular Surface Prior to Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tissue Tech Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Dystrophy, Epithelial Basement Membrane
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Active Comparator
Arm Description
prospective arm receiving cryopreserved amniotic membrane
Arm Title
Control
Arm Type
No Intervention
Arm Description
Retrospective review of debridement without cryopreserved amniotic membrane
Intervention Type
Device
Intervention Name(s)
cryopreserved amniotic membrane
Other Intervention Name(s)
Prokera Slim (PKS)
Intervention Description
placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
Primary Outcome Measure Information:
Title
Change in Intraocular Lens Calculation
Description
Assessed by corneal topography
Time Frame
Change from Baseline to 1 month
Title
Change in Intraocular Lens Power Calculation
Description
Assessed using biometry and calculated using Holladay I formula
Time Frame
Change from Baseline to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with significant EBMD that are contemplating cataract surgery.
Age range: 50 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 the investigational plan.
Subjects able and willing to complete postoperative follow-up.
Exclusion Criteria:
Subjects with known intolerance to PKS or known allergy to its preservative media.
Subjects with symblepharon or lid abnormality preventing PKS placement.
Ocular infection within 14 days prior to study entry.
Previous ocular surgery or injury within 3 months before enrollment.
Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Yeu, MD
Organizational Affiliation
Virginia Eye Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimizing the Ocular Surface Prior to Cataract Surgery
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