Optimizing the Ocular Surface Prior to Cataract Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Corneal Dystrophy, Epithelial Basement Membrane

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study

prospective arm receiving cryopreserved amniotic membrane

Group Type ACTIVE_COMPARATOR

cryopreserved amniotic membrane

Intervention Type DEVICE

placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD

Control

Retrospective review of debridement without cryopreserved amniotic membrane

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cryopreserved amniotic membrane

placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD

Intervention Type DEVICE

Other Intervention Names

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Prokera Slim (PKS)

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No