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Completed

NCT Number: NCT05326958

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRT RCM

Device

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

Other names: Heidelberg Engineering Retina Tomograph HRT 3 with the Rostock Cornea Module (HRT RCM)

HRT RCM-E

Device

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

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

Primary outcomes

  1. corneal nerve fiber length (CNFL)

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

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

  2. corneal nerve fiber density (CNFD)

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

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

  3. average corneal nerve single fiber length (CNSFL)

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

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

  4. average weighted corneal nerve fiber tortuosity (CNFTo)

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

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

  5. corneal nerve branch density (CNBD)

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

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

  6. corneal nerve connecting points (CNCP)

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

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

  7. average weighted corneal nerve fiber thickness (CNFTh)

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

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

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 14, 2022
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.