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

NCT ID: NCT05326958

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-05-31

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.

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

HRT RCM

Intervention Type: DEVICE

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

HRT RCM-E

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

HRT RCM-E

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

HRT RCM-E

Intervention Type: DEVICE

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

Interventions

HRT RCM

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

Intervention Type: DEVICE

HRT RCM-E

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

Intervention Type: DEVICE

Other Intervention Names

Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module (HRT RCM); Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module EyeGuidance functional module (HRT RCM-E)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg Engineering GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof.Dr.Rudolf Guthoff

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Rostock

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

Role: PRINCIPAL_INVESTIGATOR

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

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

Role:

Augen-Praxisklinik Minden

References

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.

Reference Type: DERIVED

PMID: 36184730 (View on PubMed)

Other Identifiers

E-2015-1

Identifier Type: -

Identifier Source: org_study_id