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Feasibility Study and Preliminary Application Study on Iris OCTA

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ClinicalTrials.gov Identifier: NCT03631108
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Conjunctivitis Glaucoma Myopia Diabetic Retinopathy Retinal Detachment Retinal Neovascularization, Unspecified Uveitis Diagnostic Test: OCTA (ZEISS)

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Feasibility Study and Preliminary Application Study on Noninvasive Iris Optical Coherence Tomography Angiography (OCTA)
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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.

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




Primary Outcome Measures :
  1. Iris Vessel Geometric Characteristics [ Time Frame: 0:00 8:00 14:00 20:00 ]
    Iris vascular density and neovascular density



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents of Shanghai and patients from Shanghai Eye Hospital will be selected.
Criteria

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.

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Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03631108     History of Changes
Other Study ID Numbers: 2018KY181
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Eye Disease Prevention and Treatment Center:
Iris Vessel
OCTA

Additional relevant MeSH terms:
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Diabetic Retinopathy
Uveitis
Neovascularization, Pathologic
Conjunctivitis
Retinal Detachment
Retinal Neovascularization
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Uveal Diseases
Metaplasia
Pathologic Processes
Conjunctival Diseases