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UWFARVO: Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion

Sponsor
Renmin Hospital of Wuhan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04075695
Collaborator
(none)
60
Enrollment
1
Location
22.8
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The changes of ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion by ultra-wide field fluorescence angiography (UWFA)

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this study, the ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion will be evaluated by ultra-wide field fluorescence angiography (UWFA). UWFA has a wider range than conventional angiography, and can clearly observe the peripheral retina. The purpose of this study is to quantitatively analyze these changes and investigate the effect on macular edema and neovascularization secondary to retinal vein occlusion.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
    Actual Study Start Date :
    Sep 18, 2019
    Anticipated Primary Completion Date :
    Aug 12, 2020
    Anticipated Study Completion Date :
    Aug 12, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Change in non-perfused areas in different retinal area [Baseline and1，2，3，6，9and 12 months]

      Change in non-perfused areas in different retinal area from Baseline to 1，2，3，6，9and 12 months

    Secondary Outcome Measures

    1. Change in best corrected visual acuity [Baseline and1，2， 3, 6, 9 and 12 months]

      Change in best corrected visual acuity from Baseline to 1，2，3，6，9and 12 months

    2. Change in central macular thickness [Baseline and1，2， 3, 6, 9 and 12 months]

      Change in central macular thickness from Baseline to 1，2，3，6，9and 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female aged 18 years or more

    2. Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema

    3. Duration of RVO not more than 4 months

    4. Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of RVO are also considered naive

    5. Patient who agrees to participate to the study and who has given his/her written, informed consent

    Exclusion Criteria:

    1. Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period

    2. Active or suspected ocular or periocular infection

    3. Active severe intraocular inflammation

    4. RVO complicated with neovascularization

    5. Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye

    6. Patient already included in the study for the treatment of the fellow eye

    7. Pregnant or breastfeeding woman

    8. Lack of effective contraception for women of childbearing age

    9. Patient taking part in an interventional study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renmin Hospital of Wuhan University Wuhan Hubei China 430000

    Sponsors and Collaborators

    • Renmin Hospital of Wuhan University

    Investigators

    • Principal Investigator: Renmin Hospital of Wuhan University, Renmin Hospital of Wuhan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changzheng Chen, Chief of Department of Ophthalmology, Renmin Hospital of Wuhan University
    ClinicalTrials.gov Identifier:
    NCT04075695
    Other Study ID Numbers:
    • UWFARVO
    First Posted:
    Sep 3, 2019
    Last Update Posted:
    Oct 28, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Changzheng Chen, Chief of Department of Ophthalmology, Renmin Hospital of Wuhan University
    ischemic index
    Ultra-wide field fundus fluorescein angiography
    vascular leakage index
    Additional relevant MeSH terms:
    Retinal Vein Occlusion

    Study Results

    No Results Posted as of Oct 28, 2019