Clinical trial NCT05326958: Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy
Official title: Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: corneal nerve fiber length (CNFL)
timeFrame: Through study completion, an average of 1 day to upto 3 days
measure: corneal nerve fiber density (CNFD)
timeFrame: Through study completion, an average of 1 day to upto 3 days
measure: average corneal nerve single fiber length (CNSFL)
timeFrame: Through study completion, an average of 1 day to upto 3 days
measure: average weighted corneal nerve fiber tortuosity (CNFTo)
timeFrame: Through study completion, an average of 1 day to upto 3 days
measure: corneal nerve branch density (CNBD)
timeFrame: Through study completion, an average of 1 day to upto 3 days
measure: corneal nerve connecting points (CNCP)
timeFrame: Through study completion, an average of 1 day to upto 3 days
measure: average weighted corneal nerve fiber thickness (CNFTh)
timeFrame: Through study completion, an average of 1 day to upto 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsmedizin Rostock
name: Prof.Dr.Rudolf Guthoff
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz- und Diabeteszentrum NRW, UKRUB, Universitätsklinik der Ruhr Universität Bochum
name: Univ.Prof.Dr.med.Dr.h.c.Diethelm Tschöpe
role: PRINCIPAL_INVESTIGATOR
affiliation: Augen-Praxisklinik Minden
name: Priv.-Dozent Dr. med.Hans-Joachim Hettlich
References:
citation: 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.