NCT02763605

Brief Summary

Acanthamoebic keratitis is an important corneal disease which may cause severe complication. The difficulty in diagnosis, the difficulty in treatment, and the long treatment process are factors leading to the poor prognosis of these patients. In this retrospective study, the investigators try to analyze the tissue proven Acanthamoebic keratitis diagnosed in our hospital. The investigators will focus on the in vivo confocal microscopic results, the medical history and the medical/surgical treatment outcome. The investigators will collect the tissue proven cases according to the data provided by laboratory diagnosis department and pathological department. The in vivo confocal microscopic results will be collected and analyzed. The investigators will also look through the photography of the external eyes from data stored in PAC system. The medical history and treatment outcome will be studied from clinical chart review. From this study, the investigators aimed to find out a easy way of diagnosing Acanthamoebic keratitis from in vivo confocal microscopy, and find out a better way for treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

April 12, 2016

Last Update Submit

May 5, 2016

Conditions

Keywords

Acanthamoeba Keratitisin vivo confocal microscopic

Outcome Measures

Primary Outcomes (1)

  • Number of participants with typical image finding under an in vivo confocal microscope (Confoscan 3.4.1; Nidek Technologies, Padova, Italy)

    through study completion, an average of about 10 year microscope diagnosis and disease progress prediction of patients with Acanthamoe

Study Arms (1)

patients diagnosed with acanthamoeba keratitis

Inclusion Criteria: \- All patients presenting to National Taiwan University Department from Jun. 1st, 2003 to dec. 30th , 2016 with the tissue proven corneal AK will be included. Exclusion Criteria \- Patients with tissue proven corneal AK during from Jun. 1st, 2003 to dec. 30th , 2016, but without in vivo confocal data, or complete chart records.

Other: no intervention

Interventions

patients diagnosed with acanthamoeba keratitis

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The in vivo confocal microscopic data and medical records of all recruited patients diagnosed with Acanthamoeba Keratitis will be reviewed after approved by the NTUH Institutional Review Board Committee. Data collected include patient demographics (age, gender), local findings, external eye photos, treatment course and treatment outcome. In vivo confocal microscope exam results will be compared with the clinical manifestation.

You may qualify if:

  • presenting to National Taiwan University Department from Jun. 1st, 2003 to dec. 30th , 2016
  • suspecting Acanthamoeba Keratitis by the ophthalmologist
  • drug treatment as Acanthamoeba Keratitis successed
  • tissue proved to be Acanthamoeba Keratitis
  • referred from the other hospital with the diagnose of Acanthamoeba Keratitis

You may not qualify if:

  • patients suspect corneal Acanthamoeba Keratitis from Jun. 1st, 2003 to dec. 30th , 2013, but without in vivo confocal data, or complete chart records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Related Publications (13)

  • Naginton J, Watson PG, Playfair TJ, McGill J, Jones BR, Steele AD. Amoebic infection of the eye. Lancet. 1974 Dec 28;2(7896):1537-40. doi: 10.1016/s0140-6736(74)90285-2. No abstract available.

    PMID: 4140981BACKGROUND
  • Mathers WD, Sutphin JE, Folberg R, Meier PA, Wenzel RP, Elgin RG. Outbreak of keratitis presumed to be caused by Acanthamoeba. Am J Ophthalmol. 1996 Feb;121(2):129-42. doi: 10.1016/s0002-9394(14)70577-x.

    PMID: 8623882BACKGROUND
  • Claerhout I, Goegebuer A, Van Den Broecke C, Kestelyn P. Delay in diagnosis and outcome of Acanthamoeba keratitis. Graefes Arch Clin Exp Ophthalmol. 2004 Aug;242(8):648-53. doi: 10.1007/s00417-003-0805-7.

    PMID: 15221303BACKGROUND
  • Winchester K, Mathers WD, Sutphin JE, Daley TE. Diagnosis of Acanthamoeba keratitis in vivo with confocal microscopy. Cornea. 1995 Jan;14(1):10-7.

    PMID: 7712728BACKGROUND
  • Matsumoto Y, Dogru M, Sato EA, Katono Y, Uchino Y, Shimmura S, Tsubota K. The application of in vivo confocal scanning laser microscopy in the management of Acanthamoeba keratitis. Mol Vis. 2007 Jul 25;13:1319-26.

    PMID: 17679934BACKGROUND
  • Parmar DN, Awwad ST, Petroll WM, Bowman RW, McCulley JP, Cavanagh HD. Tandem scanning confocal corneal microscopy in the diagnosis of suspected acanthamoeba keratitis. Ophthalmology. 2006 Apr;113(4):538-47. doi: 10.1016/j.ophtha.2005.12.022.

    PMID: 16581415BACKGROUND
  • Yokogawa H, Kobayashi A, Yamazaki N, Ishibashi Y, Oikawa Y, Tokoro M, Sugiyama K. Bowman's layer encystment in cases of persistent Acanthamoeba keratitis. Clin Ophthalmol. 2012;6:1245-51. doi: 10.2147/OPTH.S34695. Epub 2012 Aug 2.

    PMID: 22927735BACKGROUND
  • Rezaei Kanavi M, Naghshgar N, Javadi MA, Sadat Hashemi M. Various confocal scan features of cysts and trophozoites in cases with Acanthamoeba keratitis. Eur J Ophthalmol. 2012;22 Suppl 7:S46-50. doi: 10.5301/ejo.5000139.

    PMID: 22427148BACKGROUND
  • Pfister DR, Cameron JD, Krachmer JH, Holland EJ. Confocal microscopy findings of Acanthamoeba keratitis. Am J Ophthalmol. 1996 Feb;121(2):119-28. doi: 10.1016/s0002-9394(14)70576-8.

    PMID: 8623881BACKGROUND
  • Shiraishi A, Uno T, Oka N, Hara Y, Yamaguchi M, Ohashi Y. In vivo and in vitro laser confocal microscopy to diagnose acanthamoeba keratitis. Cornea. 2010 Aug;29(8):861-5. doi: 10.1097/ICO.0b013e3181ca36b6.

    PMID: 20508505BACKGROUND
  • Dart JK, Saw VP, Kilvington S. Acanthamoeba keratitis: diagnosis and treatment update 2009. Am J Ophthalmol. 2009 Oct;148(4):487-499.e2. doi: 10.1016/j.ajo.2009.06.009. Epub 2009 Aug 5.

    PMID: 19660733BACKGROUND
  • Radford CF, Lehmann OJ, Dart JK. Acanthamoeba keratitis: multicentre survey in England 1992-6. National Acanthamoeba Keratitis Study Group. Br J Ophthalmol. 1998 Dec;82(12):1387-92. doi: 10.1136/bjo.82.12.1387.

    PMID: 9930269BACKGROUND
  • Oldenburg CE, Acharya NR, Tu EY, Zegans ME, Mannis MJ, Gaynor BD, Whitcher JP, Lietman TM, Keenan JD. Practice patterns and opinions in the treatment of acanthamoeba keratitis. Cornea. 2011 Dec;30(12):1363-8. doi: 10.1097/ICO.0b013e31820f7763.

    PMID: 21993459BACKGROUND

MeSH Terms

Conditions

Acanthamoeba Keratitis

Condition Hierarchy (Ancestors)

Eye Infections, ParasiticParasitic DiseasesInfectionsAmebiasisProtozoan InfectionsKeratitisCorneal DiseasesEye DiseasesEye Infections

Study Officials

  • Wei-Li Chen, MD,PHD

    professor of National Taiwan University

    STUDY DIRECTOR

Central Study Contacts

Chia-ju Lu, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 12, 2016

First Posted

May 5, 2016

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

May 9, 2016

Record last verified: 2016-05

Locations