NCT02222857

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
Last Updated

April 26, 2018

Status Verified

August 1, 2014

Enrollment Period

Same day

First QC Date

August 20, 2014

Last Update Submit

April 24, 2018

Conditions

Keywords

Acute retinal necrosisRetinal detachmentLaser photocoagulationVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

    Best-corrected visual acuity during follow up and its correlated factors

    1 year

Secondary Outcomes (1)

  • Retinal status

    1 year

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute retinal necrosis

You may qualify if:

  • ●Patients with clinical diagnosis of acute retinal necrosis.

You may not qualify if:

  • Patients with history of retinal detachment.
  • Patients with history of other causes of severe retinal atrophy or necrosis.
  • HIV positive patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Retinal Necrosis Syndrome, AcuteRetinal Detachment

Condition Hierarchy (Ancestors)

RetinitisRetinal DiseasesEye Diseases

Study Officials

  • Chang-Ping Lin, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 21, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 26, 2018

Record last verified: 2014-08

Locations