Status:
COMPLETED
Repeatability of Static & Dynamic Composite Confocal Microscopy for Assessment of the Corneal Nerve Fiber Plexus in Early Diabetic Polyneuropathy
Lead Sponsor:
Heidelberg Engineering GmbH
Conditions:
Normal Eyes of Subjects Without Diabetes Mellitus
Subjects With Diabetes Mellitus Type 2 Without Coexisting DPN
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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)
- 5% \< HbA1c ≤ 9.5%
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05326958
Start Date
July 1 2016
End Date
May 1 2018
Last Update
May 25 2022
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