ConjunctivitisNCT03631108

Feasibility Study and Preliminary Application Study on Iris OCTA

An observational study of Conjunctivitis and Glaucoma, run by Shanghai Eye Disease Prevention and Treatment Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Conjunctivitis, Glaucoma, Myopia
What is being tested?: OCTA (ZEISS)
Type of treatment: Injection or infusion
How many people: 4,000 participants
Where: No sites listed yet
Study dates: Oct 2018to Jun 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

Patients who can not cooperate with the examination.

About this study

Official title: 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.

Read the detailed description

Feasibility study of iris OCTA technology
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.
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.
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.
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: Conjunctivitis, Glaucoma, Myopia, Diabetic Retinopathy, Retinal Detachment, Retinal Neovascularization, Unspecified
Being tested: OCTA (ZEISS)
Keywords: Iris Vessel, OCTA
Medical subject headings: Conjunctivitis, Glaucoma, Myopia, Diabetic Retinopathy, Retinal Detachment, Retinal Neovascularization, Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03631108
Study group	Role	What they receive
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. Receives: Diagnostic Test: OCTA (ZEISS)
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. Receives: Diagnostic Test: OCTA (ZEISS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Iris Vessel Geometric Characteristics
Iris vascular density and neovascular density
Measured: 0:00 8:00 14:00 20:00

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2018Jun 2019

First posted15 Aug 2018
Study startOct 2018 (estimated)
Primary completionApr 2019 (estimated)
Study completionJun 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ConjunctivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 4,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03631108
Sponsor's protocol ID: 2018KY181
Status last verified: Sep 2018
First submitted: 12 Aug 2018
Last updated: 6 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 38308203
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.
PubMed 34781913

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic

All Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study and Preliminary Application Study on Noninvasive Iris Optical Coherence Tomography Angiography (OCTA)
ClinicalTrials.gov ID: NCT03631108
Acronym / sponsor ID: 2018KY181
Conditions: Conjunctivitis, Glaucoma, Myopia, Diabetic Retinopathy, Retinal Detachment, Retinal Neovascularization, Unspecified
Keywords: Iris Vessel, OCTA
Study type: Observational
Recruitment status: Unknown status
Enrolment: 4,000 participants (estimated)
Lead sponsor: Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
Study start: Oct 2018 (estimated)
Primary completion: Apr 2019 (estimated)
Study completion: Jun 2019 (estimated)
First posted: 15 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Feasibility study of iris OCTA technology
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.
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.
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.
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 design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
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	–	Diagnostic Test: 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	–	Diagnostic Test: 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.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Residents of Shanghai and patients from Shanghai Eye Hospital will be selected.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Patients who can not cooperate with the examination.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OCTA (ZEISS)All participants will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens.	Diagnostic test	Ocular surgery patients, Patients using eye drops

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
Derived from this study: PubMed 38308203Cui 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.
Derived from this study: PubMed 34781913Jia 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.
Individual participant dataSharing planned: Undecided

Related trials for Conjunctivitis

RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Conjunctivitis and Glaucoma, run by Shanghai Eye Disease Prevention and Treatment Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Iris Vessel Geometric Characteristics (time frame: 0:00 8:00 14:00 20:00). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03631108, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018; AzTrials last refreshed its copy on 27 Oct 2026.