NCT03631108

Brief Summary

All participants will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens. The main outcomes are iris blood flow density and vascular density.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

August 12, 2018

Last Update Submit

September 5, 2018

Conditions

Keywords

Iris VesselOCTA

Outcome Measures

Primary Outcomes (1)

  • Iris Vessel Geometric Characteristics

    Iris vascular density and neovascular density

    0:00 8:00 14:00 20:00

Study Arms (4)

Normal Population

Normal population with different gender, different age different, different blood pressure, different ocular pressure, etc. All participants will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens.

Patients with common ophthalmic diseases

(1) conjunctivitis; (2) glaucoma; (3) childhood myopia; (4) uveitis; (5) diabetic retinopathy; (6) retinal detachment; (7) fundus neovascularization. All patients will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens.

Patients using eye drops

(1) conjunctivitis patients treated with levofloxacin antibiotics; (2) glaucoma patients treated with prostaglandins, adrenaline or receptor blockers drugs; (3) childhood myopia patients treated with atropine drugs; (4) uveitis patients treated with hormones treatment. (5) diabetic retinopathy patients treated with vasodilator. All patients will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens before and after eyedrops.

Diagnostic Test: OCTA (ZEISS)

Ocular surgery patients

(1) cataract, phacoemulsification + intraocular lens implantation; (2) glaucoma, iridectomy; (3) fundus neovascularization, intraocular injection of anti-VEGF; (4) diabetic retinopathy, vitrectomy. All patients will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens before and after surgery.

Diagnostic Test: OCTA (ZEISS)

Interventions

OCTA (ZEISS)DIAGNOSTIC_TEST

All participants will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens.

Ocular surgery patientsPatients using eye drops

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of Shanghai and patients from Shanghai Eye Hospital will be selected.

You may qualify if:

  • Healthy volunteers and ophthalmological patients who can understand and agree to cooperate this study will be included.

You may not qualify if:

  • Patients who can not cooperate with the examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cui L, Xiao Y, Xiang Z, Chen Z, Yang C, Zou H. Study on the correlation between iris blood flow, iris thickness and pupil diameter in the resting state and after pharmacological mydriasis in patients with diabetes mellitus. BMC Ophthalmol. 2024 Feb 2;24(1):52. doi: 10.1186/s12886-024-03322-y.

  • Jia Y, Xue W, Tong X, Wang Y, Cui L, Zou H. Quantitative analysis and clinical application of iris circulation in ischemic retinal disease. BMC Ophthalmol. 2021 Nov 15;21(1):393. doi: 10.1186/s12886-021-02165-1.

MeSH Terms

Conditions

ConjunctivitisGlaucomaMyopiaDiabetic RetinopathyRetinal DetachmentRetinal NeovascularizationUveitis

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesOcular HypertensionRefractive ErrorsRetinal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsUveal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 15, 2018

Study Start

October 1, 2018

Primary Completion

April 1, 2019

Study Completion

June 1, 2019

Last Updated

September 6, 2018

Record last verified: 2018-09