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

NCT05326958 | Completed

• 1 other identifier: E-2015-1
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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).

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

Outcome Measures

Primary Outcomes (7)

• corneal nerve fiber length (CNFL)

  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)

  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)

  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)

  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)

  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)

  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)

  Acquired image processed to obtain parameters required to calculate nerve fibre metrics

  Through study completion, an average of 1 day to upto 3 days

Study Arms (3)

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).

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).

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).

Device: HRT RCM-E

Interventions

HRT RCM DEVICE

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)

Normal Eyes of Subjects without DM

HRT RCM-E DEVICE

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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• % \< HbA1c ≤ 9.5%

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Related Publications (1)

• 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.

  PMID: 36184730 DERIVED

Study Officials

• Prof.Dr.Rudolf Guthoff

  Universitätsmedizin Rostock

  PRINCIPAL INVESTIGATOR

• Univ.Prof.Dr.med.Dr.h.c.Diethelm Tschöpe

  Herz- und Diabeteszentrum NRW, UKRUB, Universitätsklinik der Ruhr Universität Bochum

  PRINCIPAL INVESTIGATOR

• Priv.-Dozent Dr. med.Hans-Joachim Hettlich

  Augen-Praxisklinik Minden

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 14, 2022
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 25, 2022

Record last verified: 2022-05