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

NCT05326958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-05-25

No results posted yet for this study

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).

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

Interventions

DEVICE

HRT RCM

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

DEVICE

HRT RCM-E

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

Sponsors & Collaborators

  • Heidelberg Engineering GmbH

    lead INDUSTRY

Principal Investigators

  • Prof.Dr.Rudolf Guthoff · Universitätsmedizin Rostock

  • Univ.Prof.Dr.med.Dr.h.c.Diethelm Tschöpe · Herz- und Diabeteszentrum NRW, UKRUB, Universitätsklinik der Ruhr Universität Bochum

  • Priv.-Dozent Dr. med.Hans-Joachim Hettlich · Augen-Praxisklinik Minden

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-12-31
Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05326958 on ClinicalTrials.gov