Back to resultsEvaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Primary Purpose
Diabetes Mellitus, Diabetic Retinopathy, Nerve Injury
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
routine ophthalmic examination
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
- The third affiliated hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
T2DM Patients
healthy control subjects
Arm Description
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.
All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
Outcomes
Primary Outcome Measures
Peripapillary RNFL thickness
Peripapillary RNFL thickness
GCL+ in the macular area obtained using the 3D wide mode
GCL+ in the macular area obtained using the 3D wide mode
Retinal thickness in all macular regions
Retinal thickness in all macular regions
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
Secondary Outcome Measures
Full Information
NCT ID
NCT03970161
First Posted
May 22, 2019
Last Updated
May 29, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT03970161
Brief Title
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Official Title
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Retinopathy, Nerve Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T2DM Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
healthy control subjects
Arm Type
Experimental
Arm Description
All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
Intervention Type
Device
Intervention Name(s)
routine ophthalmic examination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peripapillary RNFL thickness
Description
Peripapillary RNFL thickness
Time Frame
96 weeks
Title
GCL+ in the macular area obtained using the 3D wide mode
Description
GCL+ in the macular area obtained using the 3D wide mode
Time Frame
96 weeks
Title
Retinal thickness in all macular regions
Description
Retinal thickness in all macular regions
Time Frame
96 weeks
Title
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
Description
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
Time Frame
96 weeks
Title
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
Description
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Zhu
Phone
13826452564
Email
0628zhuxiang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Zhu, Dorctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The third affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Zhu, Doctor
Phone
13826452564
Email
0628zhuxiang@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
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