Optimizing the Ocular Surface Prior to Cataract Surgery
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedMarch 19, 2019
March 1, 2019
10 months
April 25, 2016
January 18, 2019
March 5, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Intraocular Lens Calculation
Assessed by corneal topography
Change from Baseline to 1 month
Change in Intraocular Lens Power Calculation
Assessed using biometry and calculated using Holladay I formula
Change from Baseline to 1 month
Study Arms (2)
Study
ACTIVE COMPARATORprospective arm receiving cryopreserved amniotic membrane
Control
NO INTERVENTIONRetrospective review of debridement without cryopreserved amniotic membrane
Interventions
placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Results Point of Contact
- Title
- VP Medical Affairs
- Organization
- TissueTech
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Yeu, MD
Virginia Eye Consultants
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2016
First Posted
May 10, 2016
Study Start
March 1, 2016
Primary Completion
January 1, 2017
Study Completion
April 1, 2018
Last Updated
March 19, 2019
Results First Posted
March 5, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share