Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
May 29, 2019 updated by: Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University
The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study.
Patients with retinal microangioma are excluded by FFA.
The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.
Study Type
Interventional
Enrollment (Anticipated)
720
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510630
- Recruiting
- The Third Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Xiang Zhu, Doctor
- Phone Number: 13826452564
- Email: 0628zhuxiang@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with T2DM
- Patients without microangioma
Exclusion Criteria:
- Patients with any other ocular disease that might affect retinal nerve injury
- Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
- Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
- Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: T2DM Patients
Patients without microangioma changes undergoing FFA examination were included in the present study.
All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
|
Routine ophthalmic examination, including slit lamp, intraocular pressure, and fundus examinations using direct or indirect ophthalmoscopy after pupil dilation and optical coherence tomography (OCT) examination.
Patients with DM also underwent fundus fluorescein angiography (FFA) examination.
|
|
Experimental: healthy control subjects
All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
|
Routine ophthalmic examination, including slit lamp, intraocular pressure, and fundus examinations using direct or indirect ophthalmoscopy after pupil dilation and optical coherence tomography (OCT) examination.
Patients with DM also underwent fundus fluorescein angiography (FFA) examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripapillary RNFL thickness
Time Frame: 96 weeks
|
Peripapillary RNFL thickness
|
96 weeks
|
|
GCL+ in the macular area obtained using the 3D wide mode
Time Frame: 96 weeks
|
GCL+ in the macular area obtained using the 3D wide mode
|
96 weeks
|
|
Retinal thickness in all macular regions
Time Frame: 96 weeks
|
Retinal thickness in all macular regions
|
96 weeks
|
|
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
Time Frame: 96 weeks
|
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
|
96 weeks
|
|
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
Time Frame: 96 weeks
|
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
|
96 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiang Zhu, Dorctor, Third Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2019
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
May 22, 2019
First Submitted That Met QC Criteria
May 29, 2019
First Posted (Actual)
May 31, 2019
Study Record Updates
Last Update Posted (Actual)
May 31, 2019
Last Update Submitted That Met QC Criteria
May 29, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Retinal nerve injury in T2DM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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