Optimizing the Ocular Surface Prior to Cataract Surgery

T

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

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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