Optimizing the Ocular Surface Prior to Cataract Surgery

TissueTech

Status: Completed

Conditions: Corneal Dystrophy, Epithelial Basement Membrane

Treatments: Device: cryopreserved amniotic membrane

Study type: Interventional

Funder types: Industry

Identifiers

NCT02766907

P015-2

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Study

Active Comparator group

Description:

prospective arm receiving cryopreserved amniotic membrane

Treatment:

Device: cryopreserved amniotic membrane

Control

No Intervention group

Description:

Retrospective review of debridement without cryopreserved amniotic membrane