NCT05326958

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Heidelberg Engineering GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-12-01
• Completion: 2018-05-01
• First posted: 2022-04-14
• Last updated: 2022-05-25