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出境医 / 临床实验 / Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy

Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Nerve Injury Device: routine ophthalmic examination Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
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.
 Device: routine 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.
 Device: routine 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.
Outcome Measures
Primary Outcome Measures :
  1. Peripapillary RNFL thickness [ Time Frame: 96 weeks ]
    Peripapillary RNFL thickness

  2. 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

  3. Retinal thickness in all macular regions [ Time Frame: 96 weeks ]
    Retinal thickness in all macular regions

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with T2DM
  2. Patients without microangioma

Exclusion Criteria:

  1. Patients with any other ocular disease that might affect retinal nerve injury
  2. Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
  3. Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
  4. Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.
Contacts and Locations

Contacts
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Contact: Xiang Zhu 13826452564 0628zhuxiang@163.com

Locations
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China, Guangdong
The third affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Xiang Zhu, Doctor    13826452564    0628zhuxiang@163.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Xiang Zhu, Dorctor Third Affiliated Hospital, Sun Yat-Sen University
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE May 29, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Peripapillary RNFL thickness [ Time Frame: 96 weeks ]
    Peripapillary RNFL thickness
  • 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
  • Retinal thickness in all macular regions [ Time Frame: 96 weeks ]
    Retinal thickness in all macular regions
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
Official Title  ICMJE Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus
  • Diabetic Retinopathy
  • Nerve Injury
Intervention  ICMJE Device: routine 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: routine ophthalmic examination
  • Experimental: healthy control subjects
    All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
    Intervention: Device: routine ophthalmic examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019) 		720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with T2DM
  2. Patients without microangioma

Exclusion Criteria:

  1. Patients with any other ocular disease that might affect retinal nerve injury
  2. Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
  3. Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
  4. Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970161
Other Study ID Numbers  ICMJE Retinal nerve injury in T2DM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Third Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiang Zhu, Dorctor Third Affiliated Hospital, Sun Yat-Sen University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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