NCT03970161

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2019

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 22, 2019

Last Update Submit

May 29, 2019

Conditions

Diabetes MellitusDiabetic RetinopathyNerve Injury

Outcome Measures

Primary Outcomes (5)

  • Peripapillary RNFL thickness

    Peripapillary RNFL thickness

    96 weeks

  • GCL+ in the macular area obtained using the 3D wide mode

    GCL+ in the macular area obtained using the 3D wide mode

    96 weeks

  • Retinal thickness in all macular regions

    Retinal thickness in all macular regions

    96 weeks

  • 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

  • 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

Study Arms (2)

T2DM Patients

EXPERIMENTAL

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

healthy control subjects

EXPERIMENTAL

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

Device: routine ophthalmic examination

Interventions

routine ophthalmic examinationDEVICE

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.

T2DM Patientshealthy control subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with T2DM
  • Patients without microangioma

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Xiang Zhu, Dorctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Zhu

CONTACT

138264525640628zhuxiang@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 31, 2019

Study Start

May 29, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)