Macular EdemaNCT05372562
Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX
An observational study of Macular Edema, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Edema
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who were diagnosed as postoperative CME after successful phacoemulsification or vitrectomy and administrated with intravitreal dexamethasone implant (OZURDEX, Allergan, Inc, California, USA) injection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191
About this study
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.
Read the 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
- Conditions
- Macular Edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measurement of best-corrected visual acuity (BCVA) by Snellen scale and was converted into logarithmic scale (LogMAR).
Measured: All patients underwent the examination at baseline and changes were followed up at months 1, 2, 3 and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Jul 2017
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Zhang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372562
- Sponsor's protocol ID
- IRB00006761-M2022205
- Status last verified
- May 2022
- First submitted
- 22 Apr 2022
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX
- ClinicalTrials.gov ID
- NCT05372562
- Acronym / sponsor ID
- IRB00006761-M2022205
- Conditions
- Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who were diagnosed as postoperative CME after successful phacoemulsification or vitrectomy and administrated with intravitreal dexamethasone implant (OZURDEX, Allergan, Inc, California, USA) injection
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best corrected visual acuity
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: All patients underwent the examination at baseline and changes were followed up at months 1, 2, 3 and 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.