Skip to main content
OpenTrials
Completed

NCT Number: NCT02766907

Optimizing the Ocular Surface Prior to Cataract Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Corneal Dystrophy, Epithelial Basement Membrane

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cryopreserved amniotic membrane

Device

placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD

Other names: Prokera Slim (PKS)

Primary outcomes

  1. Change in Intraocular Lens Calculation

    Time frame: Change from Baseline to 1 month

    Assessed by corneal topography

  2. Change in Intraocular Lens Power Calculation

    Time frame: Change from Baseline to 1 month

    Assessed using biometry and calculated using Holladay I formula

Sponsors and collaborators

Lead sponsor

BioTissue Holdings, Inc

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 10, 2016
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.