Feasibility Study and Preliminary Application Study on Iris OCTA

• Conditions: Glaucoma; Diabetic Retinopathy; Retinal Neovascularization, Unspecified; Myopia; Retinal Detachment; Conjunctivitis; Uveitis
• Interventions: Diagnostic Test: OCTA (ZEISS)

• Registration Number: NCT03631108
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-12
• Study First Posted: 2018-08-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06
• Study Start: 2018-10
• Primary Completion: 2019-04
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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

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Exclusion Criteria

• Patients who can not cooperate with the examination.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients using eye drops	OCTA (ZEISS)	(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.
Ocular surgery patients	OCTA (ZEISS)	(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.

Primary Outcome Measures

Name	Time	Method
Iris Vessel Geometric Characteristics	0:00 8:00 14:00 20:00	Iris vascular density and neovascular density