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
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|Condition or disease||Intervention/treatment||Phase|
|Corneal Dystrophy, Epithelial Basement Membrane||Device: cryopreserved amniotic membrane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Change in Intraocular Lens Calculation [ Time Frame: Change from Baseline to 1 month ]Assessed by corneal topography
- Change in Intraocular Lens Power Calculation [ Time Frame: Change from Baseline to 1 month ]Assessed using biometry and calculated using Holladay I formula
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, Virginia|
|Virginia Eye Consultants|
|Norfolk, Virginia, United States, 23502|
|Principal Investigator:||Elizabeth Yeu, MD||Virginia Eye Consultants|
|Responsible Party:||Tissue Tech Inc.|
|Other Study ID Numbers:||
|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|
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn