Acute Retinal NecrosisNCT03260049
The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients
An observational study of Acute Retinal Necrosis, run by Chongqing Medical University.
Trial summary
The records of patients who were diagnosed with ARN between April 2010 and February 2017 were analyzed.A retrospective review of the treatment options and outcomes of the these patients was performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Retinal Necrosis
- What is being tested?
- pars plana vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Feb 2017
- 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 18 years and older
- No healthy volunteers
- Adult, Older adult
Study population: ARN patients
Who may be able to join
- ARN was diagnosed according to the American Uveitis Society Diagnostic Criteria (1994)
Who cannot join
- -
About this study
The records of patients who were diagnosed with ARN between April 2010 and February 2017 were analyzed.A retrospective review of the treatment options and outcomes of the these patients was performed.
- Conditions
- Acute Retinal Necrosis
- Being tested
- pars plana vitrectomy
- Medical subject headings
- Retinal Necrosis Syndrome, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomyProcedure or surgery
Also called systemic antiviral medications
pars plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | there was no retinal detachment (RD) at the first visit. The group 1 patients were treated with systemic antiviral medications, as well as with intravitreal antiviral injections | |
| 2 | there was no RD at the first visit. The group 2 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection. Receives: Procedure: pars plana vitrectomy | |
| 3 | there was RD at the first visit. The group 3 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection Receives: Procedure: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Measured: 1 year
Secondary outcomes (1)
retinal detachement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startApr 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Retinal NecrosisStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulin Liu, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260049
- Sponsor's protocol ID
- ChongqingMU-2
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Necessity and Optimal Time for Performing Pars Plana Vitrectomy in Acute Retinal Necrosis Patients
- ClinicalTrials.gov ID
- NCT03260049
- Acronym / sponsor ID
- ChongqingMU-2
- Conditions
- Acute Retinal Necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Aug 2017 (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.
The records of patients who were diagnosed with ARN between April 2010 and February 2017 were analyzed.A retrospective review of the treatment options and outcomes of the these patients was performed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –there was no retinal detachment (RD) at the first visit. The group 1 patients were treated with systemic antiviral medications, as well as with intravitreal antiviral injections |
| 2 | – | Procedure: pars plana vitrectomythere was no RD at the first visit. The group 2 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection. |
| 3 | – | Procedure: pars plana vitrectomythere was RD at the first visit. The group 3 patients were treated with systemic antiviral medications and PPV plus silicone oil tamponade and intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARN patients
Key inclusion criteria (1 listed)
- ARN was diagnosed according to the American Uveitis Society Diagnostic Criteria (1994)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pars plana vitrectomyAlso: systemic antiviral medicationspars plana vitrectomy | Procedure or surgery | 2, 3 |
Primary outcome
visual acuity
Time frame: 1 year
1 secondary outcome
retinal detachement
Time frame: 1 year
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 24 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Acute Retinal Necrosis
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Retinal Necrosis, run by Chongqing Medical University.
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 1 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
visual acuity (time frame: 1 year). 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 24 Aug 2017.