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CompletedNCT05326958Updated May 25, 2022

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

An interventional study of HRT RCM and HRT RCM-E in Normal Eyes of Subjects Without Diabetes Mellitus, Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN and Subjects With Diabetes Mellitus Type 2 With Coexisting Early to Moderate DPN, sponsored by Heidelberg Engineering GmbH. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by Heidelberg Engineering GmbH · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 years 8 months after the study started (first participant enrolled Jul 2016, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • 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
03

In context

Polyneuropathies

256 studies on the registry are indexed under Polyneuropathies; 50 are open to participants now.

This study's enrollment of 96 is above the median of 75 across 162 interventional studies indexed under Polyneuropathies.

Browse Polyneuropathies studies →

Lead sponsor

Heidelberg Engineering GmbH is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • 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 · Device: 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

  • 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

Interventions

  • DeviceHRT RCM

    Imaging with HRT RCM done only at site 1 (on normal eyes of subjects without DM).

    Also known as: Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module (HRT RCM)

  • DeviceHRT RCM-E

    imaging done on eyes of all enrolled subjects at site 1 and site 2.

    Also known as: Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)

06

What researchers measure

Primary outcomes

  1. corneal nerve fiber length (CNFL)

    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

  2. corneal nerve fiber density (CNFD)

    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

  3. average corneal nerve single fiber length (CNSFL)

    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

  4. average weighted corneal nerve fiber tortuosity (CNFTo)

    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

  5. corneal nerve branch density (CNBD)

    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

  6. corneal nerve connecting points (CNCP)

    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

  7. average weighted corneal nerve fiber thickness (CNFTh)

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 36184730 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05326958
Lead sponsor
Heidelberg Engineering GmbH
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
Jul 2016
Primary completion
Dec 2017
Completion
May 2018
Last update
May 25, 2022

Study contacts

Prof.Dr.Rudolf Guthoff
principal investigator · Universitätsmedizin Rostock
Univ.Prof.Dr.med.Dr.h.c.Diethelm Tschöpe
principal investigator · Herz- und Diabeteszentrum NRW, UKRUB, Universitätsklinik der Ruhr Universität Bochum
Priv.-Dozent Dr. med.Hans-Joachim Hettlich
Augen-Praxisklinik Minden

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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