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Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX

Sponsor
Peking University (Other)
Overall Status
Completed
CT.gov ID
NCT05372562
Collaborator
(none)
30
Enrollment
1
Location
58
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients who were diagnosed as postoperative CME and administrated with intravitreal OZURDEX injection were reviewed. Outcome will include best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients who were diagnosed as postoperative CME after uneventful intraocular surgery and administrated with intravitreal OZURDEX injection were reviewed. All patients underwent ophthalmic examinations at the initial visit and were followed up at months 1, 2, 3 and 6 with measurement of best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT). Recurrent CME and corresponding treatments were recorded. Risk factors of recurrent CME were analyzed

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX
    Actual Study Start Date :
    Jul 1, 2017
    Actual Primary Completion Date :
    Apr 30, 2022
    Actual Study Completion Date :
    Apr 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    patients with recurrent macular edema

    after intravitreal injection of OZURDEX, patients with macular edema relapse during follow-up were recruited.
    patients without recurrent edema

    after intravitreal injection of OZURDEX, patients without macular edema relapse during follow-up were recruited.

    Outcome Measures

    Primary Outcome Measures

    1. Best corrected visual acuity [All patients underwent the examination at baseline and changes were followed up at months 1, 2, 3 and 6.]

      Measurement of best-corrected visual acuity (BCVA) by Snellen scale and was converted into logarithmic scale (LogMAR).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who were diagnosed as postoperative CME after successful phacoemulsification or vitrectomy and administrated with intravitreal dexamethasone implant (OZURDEX, Allergan, Inc, California, USA) injection were reviewed.
    Exclusion Criteria:

    • patients with retinal vascular diseases, including retinal vein occlusion (RVO), diabetic retinopathy (DR), hypertensive retinopathy, retinal artery occlusion (RAO), Coats disease, Eales disease;

    • patients with macular disease before surgery, such as age-related macular degeneration (ARMD), macular choroidal neovascularization (CNV), myopic macular degeneration, macular hole (MH), epiretinal membrane(ERM);

    • patients with uveitis before surgery, including anterior, intermediate, posterior and generalized uveitis;

    • patients with autoimmune disease, such as ankylosing spondylitis (AS), Vogt-Koyanagi-Harada (VKH) disease, Behcet disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hosipital Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chun Zhang, professor, Peking University
    ClinicalTrials.gov Identifier:
    NCT05372562
    Other Study ID Numbers:
    • IRB00006761-M2022205
    First Posted:
    May 12, 2022
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    No Results Posted as of May 12, 2022