Feasibility Study and Preliminary Application Study on Iris OCTA

September 5, 2018 updated by: Shanghai Eye Disease Prevention and Treatment Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iris Vessel Geometric Characteristics
Time Frame: 0:00 8:00 14:00 20:00
Iris vascular density and neovascular density
0:00 8:00 14:00 20:00

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

August 12, 2018

First Submitted That Met QC Criteria

August 12, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018KY181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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