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Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy

Primary Purpose

Normal Eyes of Subjects Without Diabetes Mellitus, Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN, Subjects With Diabetes Mellitus Type 2 With Coexisting Early to Moderate DPN

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HRT RCM
HRT RCM-E
Sponsored by
Heidelberg Engineering GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Normal Eyes of Subjects Without Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All

    • Able and willing to undergo the test procedures, give consent, and to follow instructions.
    • Signed informed consent.
    • ≥18 years.

  • Part 1, Site 1

    • Normal eyes of patients without Diabetes Mellitus
    • Fasting blood glucose < 100 mg/dl
    • HbA1c ≤ 6.5%

  • Part 2, Site 2

    • Diabetes Mellitus Type 2 without coexisting DPN (NSS score ≤2 and / or NDS score ≤2)
    • Diabetes Mellitus Type 2 with coexisting early to moderate DPN. (NSS score 3-4 and / or NDS score 3-5)
    • 6.5% < HbA1c ≤ 9.5%

Exclusion Criteria:

  • Vulnerable subjects (Such as: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel (if linked to CI site), employees of the sponsor, members of the armed forces (if linked to CI site or sponsor), and persons kept in detention.)
  • Subjects unable to read or write
  • Contact lens wearers (soft and rigid)
  • Patients with symptomatic dry eye
  • Patients with conjunctivitis at the time of inclusion
  • Patients with history of corneal surgery
  • Patients with diabetic retinopathy
  • Patients with history of neuronal diseases that according to the expertise of the investigator might have an influence on corneal nerve fiber plexus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Normal Eyes of Subjects without DM

    Eyes of DM Type 2 subjects without coexisting DPN

    Eyes of DM Type 2 subjects with coexisting early to moderate DPN

    Arm Description

    Study Part 1 conducted at only site 1 . Single measurement made on 3 separate visits at site 1 (total 3 images acquired) with HRT RCM and HRT RCM-E functional module (investigational).

    Study part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational).

    Study part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational).

    Outcomes

    Primary Outcome Measures

    corneal nerve fiber length (CNFL)
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    corneal nerve fiber density (CNFD)
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    average corneal nerve single fiber length (CNSFL)
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    average weighted corneal nerve fiber tortuosity (CNFTo)
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    corneal nerve branch density (CNBD)
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    corneal nerve connecting points (CNCP)
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    average weighted corneal nerve fiber thickness (CNFTh)
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2022
    Last Updated
    May 19, 2022
    Sponsor
    Heidelberg Engineering GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05326958
    Brief Title
    Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy
    Official Title
    Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Heidelberg Engineering GmbH

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This prospective study was was divided into 2 parts and carried out at 2 sites in Germany. Part 1 assessed Repeatability in healthy, non-diabetic population (Group "control"). Part 2 collected data to evaluate the diagnostic and prognostic value of using Heidelberg Engineering Retina Tomograph (HRT) 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E) in subjects with early to moderate DPN (Groups"none" and "mild", respectively).
    Detailed Description
    Part 1 aimed to evaluate the diagnostic and prognostic value of the optimized dynamic composite corneal nerve plexus image acquisitions done with HRT RCM-E compared to standard static composite image acquisition with Heidelberg Engineering Retina Tomograph (HRT) 3 with the Rostock Cornea Module (HRT RCM). The part 2 (research part) evaluated changes in corneal nerve plexus parameters in diabetes patients without or with early to moderate Diabetic Peripheral Neuropathy (DPN) and correlated the observed changes with progression of early DPN.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Normal Eyes of Subjects Without Diabetes Mellitus, Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN, Subjects With Diabetes Mellitus Type 2 With Coexisting Early to Moderate DPN

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal Eyes of Subjects without DM
    Arm Type
    Experimental
    Arm Description
    Study Part 1 conducted at only site 1 . Single measurement made on 3 separate visits at site 1 (total 3 images acquired) with HRT RCM and HRT RCM-E functional module (investigational).
    Arm Title
    Eyes of DM Type 2 subjects without coexisting DPN
    Arm Type
    Experimental
    Arm Description
    Study part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational).
    Arm Title
    Eyes of DM Type 2 subjects with coexisting early to moderate DPN
    Arm Type
    Experimental
    Arm Description
    Study part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational).
    Intervention Type
    Device
    Intervention Name(s)
    HRT RCM
    Other Intervention Name(s)
    Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module (HRT RCM)
    Intervention Description
    Imaging with HRT RCM done only at site 1 (on normal eyes of subjects without DM).
    Intervention Type
    Device
    Intervention Name(s)
    HRT RCM-E
    Other Intervention Name(s)
    Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)
    Intervention Description
    imaging done on eyes of all enrolled subjects at site 1 and site 2.
    Primary Outcome Measure Information:
    Title
    corneal nerve fiber length (CNFL)
    Description
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    Time Frame
    Through study completion, an average of 1 day to upto 3 days
    Title
    corneal nerve fiber density (CNFD)
    Description
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    Time Frame
    Through study completion, an average of 1 day to upto 3 days
    Title
    average corneal nerve single fiber length (CNSFL)
    Description
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    Time Frame
    Through study completion, an average of 1 day to upto 3 days
    Title
    average weighted corneal nerve fiber tortuosity (CNFTo)
    Description
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    Time Frame
    Through study completion, an average of 1 day to upto 3 days
    Title
    corneal nerve branch density (CNBD)
    Description
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    Time Frame
    Through study completion, an average of 1 day to upto 3 days
    Title
    corneal nerve connecting points (CNCP)
    Description
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    Time Frame
    Through study completion, an average of 1 day to upto 3 days
    Title
    average weighted corneal nerve fiber thickness (CNFTh)
    Description
    Acquired image processed to obtain parameters required to calculate nerve fibre metrics
    Time Frame
    Through study completion, an average of 1 day to upto 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All Able and willing to undergo the test procedures, give consent, and to follow instructions. Signed informed consent. ≥18 years. Part 1, Site 1 Normal eyes of patients without Diabetes Mellitus Fasting blood glucose < 100 mg/dl HbA1c ≤ 6.5% Part 2, Site 2 Diabetes Mellitus Type 2 without coexisting DPN (NSS score ≤2 and / or NDS score ≤2) Diabetes Mellitus Type 2 with coexisting early to moderate DPN. (NSS score 3-4 and / or NDS score 3-5) 6.5% < HbA1c ≤ 9.5% Exclusion Criteria: Vulnerable subjects (Such as: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel (if linked to CI site), employees of the sponsor, members of the armed forces (if linked to CI site or sponsor), and persons kept in detention.) Subjects unable to read or write Contact lens wearers (soft and rigid) Patients with symptomatic dry eye Patients with conjunctivitis at the time of inclusion Patients with history of corneal surgery Patients with diabetic retinopathy Patients with history of neuronal diseases that according to the expertise of the investigator might have an influence on corneal nerve fiber plexus
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Prof.Dr.Rudolf Guthoff
    Organizational Affiliation
    Universitätsmedizin Rostock
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Univ.Prof.Dr.med.Dr.h.c.Diethelm Tschöpe
    Organizational Affiliation
    Herz- und Diabeteszentrum NRW, UKRUB, Universitätsklinik der Ruhr Universität Bochum
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Priv.-Dozent Dr. med.Hans-Joachim Hettlich
    Organizational Affiliation
    Augen-Praxisklinik Minden

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36184730
    Citation
    Matuszewska-Iwanicka A, Stratmann B, Stachs O, Allgeier S, Bartschat A, Winter K, Guthoff R, Tschoepe D, Hettlich HJ. Mosaic vs. Single Image Analysis with Confocal Microscopy of the Corneal Nerve Plexus for Diagnosis of Early Diabetic Peripheral Neuropathy. Ophthalmol Ther. 2022 Dec;11(6):2211-2223. doi: 10.1007/s40123-022-00574-z. Epub 2022 Oct 3.
    Results Reference
    derived

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    Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy

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