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NCT03631108 Clinical Trial

Feasibility Study and Preliminary Application Study on Iris OCTA

Glaucoma Clinical Trial

Official title:
Feasibility Study and Preliminary Application Study on Noninvasive Iris Optical Coherence Tomography Angiography (OCTA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03631108
Other study ID # 2018KY181
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2018
Est. completion date June 2019

Study information
Verified date September 2018
Source Shanghai Eye Disease Prevention and Treatment Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4000
Est. completion date June 2019
Est. primary completion date April 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• OCTA (ZEISS)
All participants will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Outcome
Type Measure Description Time frame Safety issue
Primary Iris Vessel Geometric Characteristics Iris vascular density and neovascular density 0:00 8:00 14:00 20:00
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