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

NCT ID: NCT03970161

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Diabetic Retinopathy Nerve Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

routine ophthalmic examination

Intervention Type DEVICE

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.

healthy control subjects

All of the participants enrolled in the present study underwent a systematic ophthalmic examination.

Group Type EXPERIMENTAL

routine ophthalmic examination

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Xiang Zhu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiang Zhu, Dorctor

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

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The third affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang Zhu

Role: CONTACT

Phone: 13826452564

Email: [email protected]

Facility Contacts

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Xiang Zhu, Doctor

Role: primary

Other Identifiers

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Retinal nerve injury in T2DM

Identifier Type: -

Identifier Source: org_study_id