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

Heidelberg Engineering

Status

Completed

Conditions

Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN

Normal Eyes of Subjects Without Diabetes Mellitus

Subjects With Diabetes Mellitus Type 2 With Coexisting Early to Moderate DPN

Treatments

Device: HRT RCM-E

Device: HRT RCM

Study type

Interventional

Funder types

Industry

Identifiers

NCT05326958

E-2015-1

Details and patient eligibility

About

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).

Full 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.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

96 participants in 3 patient groups

Normal Eyes of Subjects without DM

Experimental group

Description:

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).

Treatment:

Device: HRT RCM

Device: HRT RCM-E

Eyes of DM Type 2 subjects without coexisting DPN

Experimental group

Description:

Study part 2 conducted at site 2. 1 image acquired with HRT RCM-E functional module (investigational).

Treatment:

Device: HRT RCM-E

Eyes of DM Type 2 subjects with coexisting early to moderate DPN

Experimental group

Description: