Acute Retinal NecrosisNCT02222857
Prophylactic Laser Photocoagulation and Vitrectomy for Acute Retinal Necrosis
An observational study of Acute Retinal Necrosis and Retinal Detachment, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and disease course according to the diagnostic criteria proposed by the American Uveitis Society: (1) one or more foci of retinal necrosis with… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Retinal Necrosis, Retinal Detachment, Laser Photocoagulation
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Aug 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute retinal necrosis
Who may be able to join
- ●Patients with clinical diagnosis of acute retinal necrosis.
Who cannot join
- Patients with history of retinal detachment.
- Patients with history of other causes of severe retinal atrophy or necrosis.
- HIV positive patients.
Trial locations and contacts
1 site in 1 country.
About this study
Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and disease course according to the diagnostic criteria proposed by the American Uveitis Society: (1) one or more foci of retinal necrosis with discrete borders in the peripheral retina; (2) rapid progression in the absence of antiviral therapy; (3) circumferential spread; (4) occlusive vasculopathy with arteriolar involvement; and (5) a prominent inflammatory reaction in the vitreous and anterior chambers.
Herpesvirus infection, especially varicella-zoster virus (VZV) and herpes simplex virus (HSV), was presumed to be the pathogenic agent in the pathogenesis of ARN. Medical treatment with systemic antiviral agent had been the base of the therapy of ARN for decades and such treatment usually result in regression of retinitis.
Read more
However, the visual outcome of ARN remains poor. The major causes of poor visual prognosis in ARN are retinal detachment and optic nerve or macular involvement by ischemic vasculopathy. Less frequent causes include macular hole formation, macular pucker, or hypotony. Rhegmatogenous retinal detachment may occur in 75 % of the untreated eyes. It may occur weeks to months after the onset of inflammation due to delayed formation of retinal breaks, which result from the combination of necrotic retina and vitreoretinal traction.
Therefore, application of argon laser retinopexy prophylactically posterior to necrotic retina or prophylactic vitrectomy to reduce inflammatory factors and the vitreoretinal traction had been used to protect the healthy area from detachment. However, the results were varied and there is no consensus on the efficacy and indications of those prophylactic procedures. We had applied the prophylactic procedure in our treatment for ARN. We aim to access the efficacy of the treatment strategy of ARN and the correlated factors to the outcomes.
Read the detailed description
Between 1995 and 2013, the charts of 20 patients (21 eyes) with a clinical diagnosis of ARN and a complete ophthalmic examination at National Taiwan University Hospital were reviewed. The study was approved by the Ethics Committee and Institutional Review Board of National Taiwan University Hospital.
The clinical data recorded included patient demographics, refractive error, lens status, best corrected visual acuity (BCVA), all treatments and retinal anatomical status. Visual acuities and examination findings were recorded at presentation and subsequent follow-up periods for at least 6 months. The area of retina involved was determined by review of retinal drawings and fundus photos by single reader.
All the patients were admitted for intravenous injection of Acyclovir (30mg/kg/day, in 3 divided doses) for 10-14 days and then shifted to oral Acyclovir (30mg/kg/day) at least for further 10-14 days. Systemic corticosteroid and Aspirin were also given. Prophylactic laser photocoagulation was arranged on normal retina to surround the posterior edge of the active lesions if the media was clear enough to approach. If vitritis persisted without improvement under systemic antiviral agent or retinal detachment was noted, vitrectomy would be performed. Visual acuities and retinal anatomical results were recorded during follow-up after procedures. The visual acuity was converted to logarithm of the minimum angle of resolution (logMAR) values for statistical analysis.
Statistical analysis The continuous values are expressed as means ± standard deviation (SD). The differences among the continuous variables were assessed using the Mann-Whitney U test. Non-continuous variables were analyzed by Fisher's exact test. The level of statistical significance was set at p < 0.05.
- Keywords
- Acute retinal necrosis, Retinal detachment, Laser photocoagulation, Vitrectomy
- Medical subject headings
- Retinal Necrosis Syndrome, Acute, Retinal Detachment
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Best-corrected visual acuity during follow up and its correlated factors
Measured: 1 year
Secondary outcomes (1)
Retinal status
Retinal status by ophthalmoscopy to see the incidence of retinal detachment and its correlated factors
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 posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2014
- Study completionAug 2014
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.
- More trials run by National Taiwan University HospitalThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang-Ping Lin, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222857
- Sponsor's protocol ID
- 201406118RIND
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Laser Photocoagulation and Vitrectomy for Acute Retinal Necrosis
- ClinicalTrials.gov ID
- NCT02222857
- Acronym / sponsor ID
- 201406118RIND
- Keywords
- Acute retinal necrosis, Retinal detachment, Laser photocoagulation, Vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Aug 2014 (estimated)
- 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.
Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and disease course according to the diagnostic criteria proposed by the American Uveitis Society: (1) one or more foci of retinal necrosis with discrete borders in the peripheral retina; (2) rapid progression in the absence of antiviral therapy; (3) circumferential spread; (4) occlusive vasculopathy with arteriolar involvement; and (5) a prominent inflammatory reaction in the vitreous and anterior chambers.
Herpesvirus infection, especially varicella-zoster virus (VZV) and herpes simplex virus (HSV), was presumed to be the pathogenic agent in the pathogenesis of ARN. Medical treatment with systemic antiviral agent had been the base of the therapy of ARN for decades and such treatment usually result in regression of retinitis.
However, the visual outcome of ARN remains poor. The major causes of poor visual prognosis in ARN are retinal detachment and optic nerve or macular involvement by ischemic vasculopathy. Less frequent causes include macular hole formation, macular pucker, or hypotony. Rhegmatogenous retinal detachment may occur in 75 % of the untreated eyes. It may occur weeks to months after the onset of inflammation due to delayed formation of retinal breaks, which result from the combination of necrotic retina and vitreoretinal traction.
Therefore, application of argon laser retinopexy prophylactically posterior to necrotic retina or prophylactic vitrectomy to reduce inflammatory factors and the vitreoretinal traction had been used to protect the healthy area from detachment. However, the results were varied and there is no consensus on the efficacy and indications of those prophylactic procedures. We had applied the prophylactic procedure in our treatment for ARN. We aim to access the efficacy of the treatment strategy of ARN and the correlated factors to the outcomes.
Detailed description
Between 1995 and 2013, the charts of 20 patients (21 eyes) with a clinical diagnosis of ARN and a complete ophthalmic examination at National Taiwan University Hospital were reviewed. The study was approved by the Ethics Committee and Institutional Review Board of National Taiwan University Hospital.
The clinical data recorded included patient demographics, refractive error, lens status, best corrected visual acuity (BCVA), all treatments and retinal anatomical status. Visual acuities and examination findings were recorded at presentation and subsequent follow-up periods for at least 6 months. The area of retina involved was determined by review of retinal drawings and fundus photos by single reader.
All the patients were admitted for intravenous injection of Acyclovir (30mg/kg/day, in 3 divided doses) for 10-14 days and then shifted to oral Acyclovir (30mg/kg/day) at least for further 10-14 days. Systemic corticosteroid and Aspirin were also given. Prophylactic laser photocoagulation was arranged on normal retina to surround the posterior edge of the active lesions if the media was clear enough to approach. If vitritis persisted without improvement under systemic antiviral agent or retinal detachment was noted, vitrectomy would be performed. Visual acuities and retinal anatomical results were recorded during follow-up after procedures. The visual acuity was converted to logarithm of the minimum angle of resolution (logMAR) values for statistical analysis.
Statistical analysis The continuous values are expressed as means ± standard deviation (SD). The differences among the continuous variables were assessed using the Mann-Whitney U test. Non-continuous variables were analyzed by Fisher's exact test. The level of statistical significance was set at p < 0.05.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute retinal necrosis
Key inclusion criteria (1 listed)
- ●Patients with clinical diagnosis of acute retinal necrosis.
Key exclusion criteria (3 listed)
- Patients with history of retinal detachment.
- Patients with history of other causes of severe retinal atrophy or necrosis.
- HIV positive patients.
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: 1 year
Best-corrected visual acuity during follow up and its correlated factors
1 secondary outcome
Retinal status
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 26 Apr 2018.
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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.
Chang-Ping Lin, MD principal investigator
National Taiwan University Hospital
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 Acute Retinal Necrosis and Retinal Detachment, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 26 Apr 2018. 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 Taiwan. 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: 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 26 Apr 2018; AzTrials last refreshed its copy on 5 Nov 2026.