Acanthamoeba KeratitisNCT02763605
Retrospective Study of Acanthamoebic Keratitis During the Past 10 Years
An observational study of Acanthamoeba Keratitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Acanthamoeba Keratitis
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Jul 2016
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- patients suspect corneal Acanthamoeba Keratitis from Jun. 1st, 2003 to dec. 30th , 2013, but without in vivo confocal data, or complete chart records.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
About this study
Official title: Retrospective Study of the in Vivo Confocal Microscopic Findings and the Treatment Outcome of Acanthamoebic Keratitis
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.
Read the detailed description
Acanthamoeba keratitis (AK), caused by a pathogenic amoeba, is a sight-threatening corneal infection with severe pain, epithelial defect, epithelial haze, pseudodendrites, and, most characteristically, radial keratoneuritis. The corneal infection of AK was first recognized in the mid 1970s. Since then, a growing number of AK cases were diagnosed, mainly resulting from improper use of soft contact lenses.
Clinical diagnosis of AL is difficult, especially in the early phases of the disease, and it often is misdiagnosed and treated as a herpes simplex infection. It was reported a diagnostic delay of more than 18 days between onset of symptoms and start of anti- amoebic treatment results in a poor disease progress. While definitive diagnosis is made by confirmation of Acanthamoeba cysts or trophozoites in corneal lesions by staining, corneal biopsy, or tissue culturing.
In vivo confocal microscopy was considered useful in the rapid diagnosis of AK. The Acanthamoeba cysts were observed almost exclusively in the epithelial cell layer as highly reflective, round or stellate, high-contrast particles with a diameter of 10 to 20 μm. It was suggested that invasion of Acanthamoeba cysts into Bowman's layer may be a useful predictor for a persistent clinical course. The trophozoites are pear-shaped or irregularly wedge-shaped structures, some surrounded by a brilliant halo some exhibiting fine pseudopodia-like extensions, with mean size of 30.2 µm (range 19.2-55.6μm). It was reported to present in cornea stroma. Highly reflective activated keratocytes forming a honeycomb pattern change was reported to be present around the keratoneuritis. In addition, infiltration of inflammatory cells, possibly polymorphonuclear cells, was observed along with the keratocytes in cases of AK. However, the in vivo confocal microscopic findings in patients with AK is still limited. Some clinical findings may not be correlated with the reports published before.
John K.G. et al recommended clinical treatment toward Acanthamoeba keratitis using Diamidine and Biguanide which are the only two proofed Acanthamoeba cysticidal medication, while Metronidazole is effective in vivo but not in vitro. Topical steroid was considered rather controversial but important and beneficial. It was recommended to use a minimum of 2 weeks of Biguanide prior to the use of topical steroid for inflammation control. When Acanthamoeba keratitis was diagnosed early in the disease course, topical steroid can be spared for the immediate using Diamidine and Biguanide to kill pathogen. In a United Kingdom multicenter study of 218 patients, the average duration of medical therapy was 6 months (range, 0.5 to 29 months). In 2011, a little over half of respondents using corticosteroids in the treatment of Acanthamoeba keratitis. Surgical managements including epithelial debridement, cryotherapy and corneal graft surgery may itself be therapeutic if performed early and promote penetration. Therefore, when Acanthamoeba keratitis was suspected, a long-term and immediate medical treatment may be needed ,and the use of topical steroid toward Acanthamoeba keratitis is still worth investigating.
- Conditions
- Acanthamoeba Keratitis
- Being tested
- no intervention
- Keywords
- Acanthamoeba Keratitis, in vivo confocal microscopic
- Medical subject headings
- Acanthamoeba Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with typical image finding under an in vivo confocal microscope (Confoscan 3.4.1; Nidek Technologies, Padova, Italy)
Measured: through study completion, an average of about 10 year microscope diagnosis and disease progress prediction of patients with Acanthamoe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acanthamoeba KeratitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Chen, MD,PHD, Study director, professor of National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763605
- Sponsor's protocol ID
- 201312046RINB
- Status last verified
- May 2016
- First submitted
- 12 Apr 2016
- Last updated
- 9 May 2016
- Results posted
- No
Publications
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.
PubMed 4140981Mathers 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.
PubMed 8623882Claerhout 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.
PubMed 15221303Winchester K, Mathers WD, Sutphin JE, Daley TE. Diagnosis of Acanthamoeba keratitis in vivo with confocal microscopy. Cornea. 1995 Jan;14(1):10-7.
PubMed 7712728Matsumoto 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.
PubMed 17679934Parmar 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.
PubMed 16581415Yokogawa 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.
PubMed 22927735Rezaei 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.
PubMed 22427148Pfister 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.
PubMed 8623881Shiraishi 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.
PubMed 20508505Dart 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.
PubMed 19660733Radford 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.
PubMed 9930269Oldenburg 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.
PubMed 21993459
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the in Vivo Confocal Microscopic Findings and the Treatment Outcome of Acanthamoebic Keratitis
- ClinicalTrials.gov ID
- NCT02763605
- Acronym / sponsor ID
- 201312046RINB
- Conditions
- Acanthamoeba Keratitis
- Keywords
- Acanthamoeba Keratitis, in vivo confocal microscopic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 5 May 2016 (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.
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.
Detailed description
Acanthamoeba keratitis (AK), caused by a pathogenic amoeba, is a sight-threatening corneal infection with severe pain, epithelial defect, epithelial haze, pseudodendrites, and, most characteristically, radial keratoneuritis. The corneal infection of AK was first recognized in the mid 1970s. Since then, a growing number of AK cases were diagnosed, mainly resulting from improper use of soft contact lenses.
Clinical diagnosis of AL is difficult, especially in the early phases of the disease, and it often is misdiagnosed and treated as a herpes simplex infection. It was reported a diagnostic delay of more than 18 days between onset of symptoms and start of anti- amoebic treatment results in a poor disease progress. While definitive diagnosis is made by confirmation of Acanthamoeba cysts or trophozoites in corneal lesions by staining, corneal biopsy, or tissue culturing.
In vivo confocal microscopy was considered useful in the rapid diagnosis of AK. The Acanthamoeba cysts were observed almost exclusively in the epithelial cell layer as highly reflective, round or stellate, high-contrast particles with a diameter of 10 to 20 μm. It was suggested that invasion of Acanthamoeba cysts into Bowman's layer may be a useful predictor for a persistent clinical course. The trophozoites are pear-shaped or irregularly wedge-shaped structures, some surrounded by a brilliant halo some exhibiting fine pseudopodia-like extensions, with mean size of 30.2 µm (range 19.2-55.6μm). It was reported to present in cornea stroma. Highly reflective activated keratocytes forming a honeycomb pattern change was reported to be present around the keratoneuritis. In addition, infiltration of inflammatory cells, possibly polymorphonuclear cells, was observed along with the keratocytes in cases of AK. However, the in vivo confocal microscopic findings in patients with AK is still limited. Some clinical findings may not be correlated with the reports published before.
John K.G. et al recommended clinical treatment toward Acanthamoeba keratitis using Diamidine and Biguanide which are the only two proofed Acanthamoeba cysticidal medication, while Metronidazole is effective in vivo but not in vitro. Topical steroid was considered rather controversial but important and beneficial. It was recommended to use a minimum of 2 weeks of Biguanide prior to the use of topical steroid for inflammation control. When Acanthamoeba keratitis was diagnosed early in the disease course, topical steroid can be spared for the immediate using Diamidine and Biguanide to kill pathogen. In a United Kingdom multicenter study of 218 patients, the average duration of medical therapy was 6 months (range, 0.5 to 29 months). In 2011, a little over half of respondents using corticosteroids in the treatment of Acanthamoeba keratitis. Surgical managements including epithelial debridement, cryotherapy and corneal graft surgery may itself be therapeutic if performed early and promote penetration. Therefore, when Acanthamoeba keratitis was suspected, a long-term and immediate medical treatment may be needed ,and the use of topical steroid toward Acanthamoeba keratitis is still worth investigating.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with acanthamoeba keratitis | – | Other: no interventionInclusion 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. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- patients suspect corneal Acanthamoeba Keratitis from Jun. 1st, 2003 to dec. 30th , 2013, but without in vivo confocal data, or complete chart records.
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 |
|---|---|---|
| no intervention | Other | patients diagnosed with acanthamoeba keratitis |
Primary outcome
Number of participants with typical image finding under an in vivo confocal microscope (Confoscan 3.4.1; Nidek Technologies, Padova, Italy)
Time frame: through study completion, an average of about 10 year microscope diagnosis and disease progress prediction of patients with Acanthamoe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Background: PubMed 4140981Naginton 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.
- Background: PubMed 8623882Mathers 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.
- Background: PubMed 15221303Claerhout 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.
- Background: PubMed 7712728Winchester K, Mathers WD, Sutphin JE, Daley TE. Diagnosis of Acanthamoeba keratitis in vivo with confocal microscopy. Cornea. 1995 Jan;14(1):10-7.
- Background: PubMed 17679934Matsumoto 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.
- Background: PubMed 16581415Parmar 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.
- Background: PubMed 22927735Yokogawa 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.
- Background: PubMed 22427148Rezaei 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.
- Background: PubMed 8623881Pfister 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.
- Background: PubMed 20508505Shiraishi 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.
- Background: PubMed 19660733Dart 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.
- Background: PubMed 9930269Radford 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.
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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.
Wei-Li Chen, MD,PHD study director
professor of National Taiwan University
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 Acanthamoeba Keratitis, 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 5 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: status not confirmed, as of the sponsor's last update on 9 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-ju Lu, MD (+886223123456 ext. 65197, lcjjulie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with typical image finding under an in vivo confocal microscope (Confoscan 3.4.1; Nidek Technologies, Padova, Italy) (time frame: through study completion, an average of about 10 year microscope diagnosis and disease progress prediction of patients with Acanthamoe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763605, which also lists 13 linked publications.
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 9 May 2016.