Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX

Macular Edema Clinical Trial

Official title:

Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372562
• Other study ID #: IRB00006761-M2022205
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Macular Edema

Locations

Country	Name	City	State
China	Peking University Third Hosipital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.