NCT05739487

Brief Summary

Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating visual function defects and poor prognosis. Though traditional conservative treatments are widely used, none of them is proved to be effective. A number of meta-analyses and observational studies indicate intravenous thrombolysis to be beneficial in CRAO. Selective intra-arterial thrombolysis (IAT) introducing rt-PA directly into the ophthalmic circulation by super-selective microcatheterization may reduce the complications such as intracranial and systemic hemorrhage. The residual visual field is significant for patients with CRAO who have poor central visual acuity. Thus, it is clinically significant to study the changes in visual fields in eyes with CRAO.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 13, 2023

Last Update Submit

February 21, 2023

Conditions

Central Retinal Artery OcclusionVisual FieldIntra-arterial Thrombolysis

Outcome Measures

Primary Outcomes (2)

  • Change of the mean deviation

    Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 7days

    7 days

  • Change of the visual field index

    Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 7 days

    7 days

Secondary Outcomes (2)

  • Change of best corrected visual acuity (BCVA)

    7 days

  • Adverse reactions at 7 days

    7 days

Study Arms (1)

IAT therapy

patients with central retinal artery occlusion received selective intra-arterial thrombolysis

Procedure: selective intra-arterial thrombolysis

Interventions

selective intra-arterial thrombolysisPROCEDURE

IAT introduces rt-PA (50mg) directly into the ophthalmic circulation by super-selective microcatheterization

IAT therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with non-arteritic CRAO and treated by IAT between July 2020 and March 2022 were analyzed retrospectively.

You may qualify if:

  • \. Non-arteritic CRAO with symptom duration ≤7d 2. Age from 18 years old between 80 years old 3. Qualified systemic conditions, well-controlled blood pressure, well-controlled blood glucose, qualified liver and kidney function, no allergic history to contrast agent or rt-PA.

You may not qualify if:

  • Ocular factor or disease
  • Branch retinal artery occlusion
  • Combined retinal vein occlusion
  • Suspicious ocular ischemic syndrome, such as ophthalmic artery occlusion or carotid artery occlusion
  • Existed retinal problems decreasing visual function, such as macular disease, severe nonproliferative or proliferative diabetic retinopathy, severe cataract or glaucoma
  • Central retinal artery occlusion from iatrogenic cause
  • History of thrombolysis for CRAO or CRVO
  • Systemic factors restricting thrombolysis
  • Uncontrolled hypertension (systolic blood pressure \> 180mmHg ); Uncontrolled hyperglycemia (fasting blood glucose \> 9mmol/L);
  • Coagulation disorder
  • History of intracranial hemorrhage, heart attack, cerebral infarction, or intracranial surgery within 3 mo
  • Current antithrombotic treatment
  • History of allergic reaction to contrast agent or rt-PA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Retinal Artery Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ping Fei, MD#PhD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 22, 2023

Study Start

July 1, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

CN(1)