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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03970161
• Other study ID #: Retinal nerve injury in T2DM
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2019
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiang Zhu
• Phone: 13826452564
• Email: 0628zhuxiang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Nerve Injury
• Retinal Diseases
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	The third affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripapillary RNFL thickness	Peripapillary RNFL thickness	96 weeks
Primary	GCL+ in the macular area obtained using the 3D wide mode	GCL+ in the macular area obtained using the 3D wide mode	96 weeks
Primary	Retinal thickness in all macular regions	Retinal thickness in all macular regions	96 weeks
Primary	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	96 weeks
Primary	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	96 weeks