Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedMay 12, 2022
May 1, 2022
4.8 years
April 22, 2022
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Best corrected visual acuity
Measurement of best-corrected visual acuity (BCVA) by Snellen scale and was converted into logarithmic scale (LogMAR).
All patients underwent the examination at baseline and changes were followed up at months 1, 2, 3 and 6.
Study Arms (2)
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.
Eligibility 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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 22, 2022
First Posted
May 12, 2022
Study Start
July 1, 2017
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
May 12, 2022
Record last verified: 2022-05