Normal Eyes of Subjects Without Diabetes Mellitus, Subjects With Diabetes Mellitus Type 2 With Coexisting Early to Moderate DPN, Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN
Conditions
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 (Groupsnone 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.
Interventions
DEVICEHRT RCM
Imaging with HRT RCM done only at site 1 (on normal eyes of subjects without DM).
DEVICEHRT RCM-E
imaging done on eyes of all enrolled subjects at site 1 and site 2.
Sponsors
Heidelberg Engineering GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| average weighted corneal nerve fiber thickness (CNFTh) | 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 length (CNFL) | 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) | 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) | 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) | 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) | 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) | Through study completion, an average of 1 day to upto 3 days | Acquired image processed to obtain parameters required to calculate nerve fibre metrics |
Outcome results
None listed