Optimizing the Ocular Surface Prior to Cataract Surgery

Completed · Not applicable

Conditions studied: Corneal Dystrophy, Epithelial Basement Membrane

In brief

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.

Key facts

Study ID

NCT02766907

Run by

BioTissue Holdings, Inc

People needed

20

Starts

2016-03-01

Expected to finish

2018-04-01

Last updated by the study team

2019-03-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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