NCT01170481

Brief Summary

Assessment of optic disc morphology can be difficult in patients with uveitis and papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning techniques may help to detect damage to the retinal nerve fibre layer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

July 21, 2010

Last Update Submit

November 17, 2015

Conditions

UveitisGlaucoma

Keywords

anterior and intermediate uveitispapilloedema

Outcome Measures

Primary Outcomes (1)

  • Alterations of retinal nerve fibre layer by optical coherence tomography

    Baseline comparision of retinal nerve fibre layer thickness in patients with uveitis and with or without papilloedema at study entry. No follow-up examination scheduled

    once at study entry

Study Arms (3)

papilloedema without glaucoma

papilloedema with glaucoma

glaucoma without papilloedema

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients with anterior or intermediate uveitis and papillooedema in fluoreszein angiography.

You may qualify if:

  • anterior or intermediate uveitis
  • papilloedema
  • glaucoma

You may not qualify if:

  • dense cataract
  • dense vitreous opacification
  • circular posterior synechiae

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology at St.-Franziskus Hospital

Münster, 48145, Germany

Location

Related Publications (1)

  • Heinz C, Kogelboom K, Heiligenhaus A. Influence of optic disc leakage on objective optic nerve head assessment in patients with uveitis. Graefes Arch Clin Exp Ophthalmol. 2016 Feb;254(2):361-4. doi: 10.1007/s00417-015-3218-5. Epub 2015 Nov 18.

    PMID: 26582161DERIVED

Related Links

MeSH Terms

Conditions

UveitisGlaucomaUveitis, IntermediatePapilledema

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesOcular HypertensionOptic Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Arnd Heiligenhaus, MD

    Department at St. Franziskus Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 27, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

April 1, 2011

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

DE(1)