Optimizing the Ocular Surface Prior to Cataract Surgery

March 5, 2019 updated by: Tissue Tech Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Eye Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study
prospective arm receiving cryopreserved amniotic membrane
Device: cryopreserved amniotic membrane
placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
Other Names:
  • Prokera Slim (PKS)
No Intervention: Control
Retrospective review of debridement without cryopreserved amniotic membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Lens Calculation
Time Frame: Change from Baseline to 1 month
Assessed by corneal topography
Change from Baseline to 1 month
Change in Intraocular Lens Power Calculation
Time Frame: Change from Baseline to 1 month
Assessed using biometry and calculated using Holladay I formula
Change from Baseline to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tissue Tech Inc.

Investigators

  • Principal Investigator: Elizabeth Yeu, MD, Virginia Eye Consultants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P015-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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