NCT02168790

Brief Summary

The investigators aimed at developing a technique to apply amniotic membrane to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). This system needs to be concordant with laws and guidelines for the use of medical and pharmaceutical products.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Feb 2011

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

June 12, 2014

Last Update Submit

June 18, 2014

Conditions

Corneal UlcersCorneal Melting

Keywords

amniotic membrane holder, aminiotic membrane transplantation

Outcome Measures

Primary Outcomes (1)

  • Slit lamp investigation of the inflammation status of the conjunctiva

    The ring of the AmnioClip touches the conjunctiva of the ocular surface. To prove side effects through the medical device the conjunctiva is controlled at every visit with microscopy using a slit lamp.

    Participants will be followed for the duration of hospital stay, an expanded average of 3 month

Study Arms (1)

Amniotic membrane ring

EXPERIMENTAL

Application of amniotic membrane device for 6-7 days.

Device: Amniotic membrane ring

Interventions

Amniotic membrane ringDEVICE

The amniotic membrane ring system (AmnioClip) is device for sutureless application of amniotic membrane to oculare surfaces. Amniotic membrane is mounted between the two rings with a specially designed, accessory mounting device.

Also known as: Amniotic membrane
Amniotic membrane ring

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ocular surface disorders and indication for amniotic membrane transplantation
  • Willingness to provide signed Informed Consent Form
  • For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
  • Ability and willingness to return for all scheduled visits and assessments

You may not qualify if:

  • An eye that, in the investigator's opinion, would not benefit from amniotic membrane transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

Location

Related Publications (2)

  • 1. Liu J, Sheha H, Fu Y et al. (2010) Update of amniotic membrane transplantation. Expert Review Ophthalmol 5:645-661 2. Dua HS, Azuara-Blanco A (1999) Amniotic membrane transplantation, Br J Ophthalmol 83:748-752 3. Daniel Meller, Mikk Pauklin, Henning Thomasen et al. (2011) Amniotic Membrane Transplantation in the Human Eye. Dtsch Arztebl Int 108: 243-8 4. Pachigolla G, Prasher P, Di Pasauale MA, Mc Culley JP, Mc Henry JG, Mootha VV, Evaluation of the role of ProKera in the mamagment of ocular surface and orbital disorders, Eye Contact Lens 2009, 35:172-175 5. Uhlig CE and Busse H, Development and evaluation of a device for sutureless and repeated application of amniotic memnbrane overlays. Cornea 29:331-5

    BACKGROUND

  • Kotomin I, Valtink M, Hofmann K, Frenzel A, Morawietz H, Werner C, Funk RH, Engelmann K. Sutureless fixation of amniotic membrane for therapy of ocular surface disorders. PLoS One. 2015 May 8;10(5):e0125035. doi: 10.1371/journal.pone.0125035. eCollection 2015.

    PMID: 25955359DERIVED

MeSH Terms

Conditions

Corneal Ulcer

Interventions

Biological Dressings

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Ilya Kotomin

    Klinikum Chemnitz gGmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 20, 2014

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2013

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

DE(1)