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

May 19, 2022 updated by: Heidelberg Engineering GmbH

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal Eyes of Subjects without DM
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).
Device: HRT RCM
Imaging with HRT RCM done only at site 1 (on normal eyes of subjects without DM).
Other Names:
  • Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module (HRT RCM)
Device: HRT RCM-E
imaging done on eyes of all enrolled subjects at site 1 and site 2.
Other Names:
  • Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)
Experimental: Eyes of DM Type 2 subjects without coexisting DPN

Study part 2 conducted at site 2.

1 image acquired with HRT RCM-E functional module (investigational).
Device: HRT RCM-E
imaging done on eyes of all enrolled subjects at site 1 and site 2.
Other Names:
  • Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)
Experimental: Eyes of DM Type 2 subjects with coexisting early to moderate DPN

Study part 2 conducted at site 2.

1 image acquired with HRT RCM-E functional module (investigational).
Device: HRT RCM-E
imaging done on eyes of all enrolled subjects at site 1 and site 2.
Other Names:
  • Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal nerve fiber length (CNFL)
Time Frame: Through study completion, an average of 1 day to upto 3 days
Acquired image processed to obtain parameters required to calculate nerve fibre metrics
Through study completion, an average of 1 day to upto 3 days
corneal nerve fiber density (CNFD)
Time Frame: Through study completion, an average of 1 day to upto 3 days
Acquired image processed to obtain parameters required to calculate nerve fibre metrics
Through study completion, an average of 1 day to upto 3 days
average corneal nerve single fiber length (CNSFL)
Time Frame: Through study completion, an average of 1 day to upto 3 days
Acquired image processed to obtain parameters required to calculate nerve fibre metrics
Through study completion, an average of 1 day to upto 3 days
average weighted corneal nerve fiber tortuosity (CNFTo)
Time Frame: Through study completion, an average of 1 day to upto 3 days
Acquired image processed to obtain parameters required to calculate nerve fibre metrics
Through study completion, an average of 1 day to upto 3 days
corneal nerve branch density (CNBD)
Time Frame: Through study completion, an average of 1 day to upto 3 days
Acquired image processed to obtain parameters required to calculate nerve fibre metrics
Through study completion, an average of 1 day to upto 3 days
corneal nerve connecting points (CNCP)
Time Frame: Through study completion, an average of 1 day to upto 3 days
Acquired image processed to obtain parameters required to calculate nerve fibre metrics
Through study completion, an average of 1 day to upto 3 days
average weighted corneal nerve fiber thickness (CNFTh)
Time Frame: Through study completion, an average of 1 day to upto 3 days
Acquired image processed to obtain parameters required to calculate nerve fibre metrics
Through study completion, an average of 1 day to upto 3 days

Collaborators and Investigators

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

Sponsor

Heidelberg Engineering GmbH

Investigators

  • Principal Investigator: Prof.Dr.Rudolf Guthoff, Universitatsmedizin Rostock
  • Principal Investigator: Univ.Prof.Dr.med.Dr.h.c.Diethelm Tschöpe, Herz- und Diabeteszentrum NRW, UKRUB, Universitätsklinik der Ruhr Universität Bochum
  • Priv.-Dozent Dr. med.Hans-Joachim Hettlich, Augen-Praxisklinik Minden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-2015-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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