Feasibility Study and Preliminary Application Study on Iris OCTA

NCT ID: NCT03631108

Last Updated: 2018-09-06

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

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-31

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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1. Feasibility study of iris OCTA technology
2. Establishment of iris OCTA database in normal population and analysis of related factors: (1) different sex; (2) different age; (3) different myopic diopter; (4) 24-hour diurnal changes from morning to night; (5) before and after mydriasis; (6) different blood pressure; (7) different intraocular pressure; (8) different blood glucose; (9) before and after exercise. (10) drinking water, tea, coffee and red wine.
3. Analysis of iris OCTA data related to eye diseases:(1) conjunctivitis; (2) glaucoma; (3) childhood myopia; (4) uveitis; (5) diabetic retinopathy; (6) retinal detachment; (7) fundus neovascularization.
4. Influence of commonly used ophthalmic drops on iris OCTA data. Observe the difference of iris OCTA test data before and after treatment: (1) conjunctivitis treated with levofloxacin antibiotics; (2) glaucoma treated with prostaglandins, adrenalines and receptor blockers; (3) childhood myopia treated with atropine drugs (4) uveitis treated with hormonal drugs. (5) diabetic retinopathy treated with vasodilator.
5. Effect on iris OCTA data before and after ophthalmic surgery. (1) cataract, phacoemulsification + intraocular lens implantation; (2) glaucoma, iridectomy; (3) fundus neovascularization, intraocular injection of anti-VEGF; (4) diabetic retinopathy, vitreous surgery.

Conditions

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Conjunctivitis Glaucoma Myopia Diabetic Retinopathy Retinal Detachment Retinal Neovascularization, Unspecified Uveitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

OCTA (ZEISS)

Intervention Type DIAGNOSTIC_TEST

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

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.

OCTA (ZEISS)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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OCTA (ZEISS)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients who can not cooperate with the examination.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 38308203 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34781913 (View on PubMed)

Other Identifiers

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2018KY181

Identifier Type: -

Identifier Source: org_study_id

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