Normal Eyes of Subjects Without Diabetes MellitusNCT05326958

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

A study testing HRT RCM and HRT RCM-E in people with Normal Eyes of Subjects Without Diabetes Mellitus and Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN, run by Heidelberg Engineering GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: 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
What is being tested?: HRT RCM and HRT RCM-E
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: No sites listed yet
Study dates: Jul 2016to May 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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%

Who cannot join

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

About this study

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.

Conditions: 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
Being tested: HRT RCM, HRT RCM-E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRT RCMDevice
Also called Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module (HRT RCM)
Imaging with HRT RCM done only at site 1 (on normal eyes of subjects without DM).
HRT RCM-EDevice
Also called Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)
imaging done on eyes of all enrolled subjects at site 1 and site 2.

Study groups in NCT05326958
Study group	Role	What they receive
Normal Eyes of Subjects without DM	Experimental	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). Receives: Device: HRT RCM; Device: HRT RCM-E
Eyes of DM Type 2 subjects without coexisting DPN	Experimental	Study part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational). Receives: Device: HRT RCM-E
Eyes of DM Type 2 subjects with coexisting early to moderate DPN	Experimental	Study part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational). Receives: Device: HRT RCM-E

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016May 2018

First posted14 Apr 2022
Study startJul 2016
Primary completionDec 2017
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Normal Eyes of Subjects Without Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05326958
Sponsor's protocol ID: E-2015-1
Status last verified: May 2022
First submitted: 29 Mar 2022
Last updated: 25 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy
ClinicalTrials.gov ID: NCT05326958
Acronym / sponsor ID: E-2015-1
Conditions: 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
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
Study start: Jul 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: May 2018 (actual)
First posted: 14 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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").

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Normal Eyes of Subjects without DM	Experimental	Device: HRT RCM, Device: HRT RCM-EStudy 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).
Eyes of DM Type 2 subjects without coexisting DPN	Experimental	Device: HRT RCM-EStudy part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational).
Eyes of DM Type 2 subjects with coexisting early to moderate DPN	Experimental	Device: HRT RCM-EStudy part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

All
Part 1, Site 1
Part 2, Site 2

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRT RCMAlso: Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module (HRT RCM)Imaging with HRT RCM done only at site 1 (on normal eyes of subjects without DM).	Device	Normal Eyes of Subjects without DM
HRT RCM-EAlso: Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)imaging done on eyes of all enrolled subjects at site 1 and site 2.	Device	Eyes of DM Type 2 subjects with coexisting early to moderate DPN, Eyes of DM Type 2 subjects without coexisting DPN, Normal Eyes of Subjects without DM

Primary outcome

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
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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
Derived from this study: PubMed 36184730Matuszewska-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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

corneal nerve fiber length (CNFL) (time frame: Through study completion, an average of 1 day to upto 3 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05326958, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.