Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-03-31
2016-09-30
Brief Summary
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Detailed Description
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The test aberrometer will be:
Peramis (Schwind Eye-tech Solutions, Kleinostheim, Germany).
Control aberrometer will be:
iDesign (AMO, Santa Clara, CA)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Myopia (Peramis)
Peramis aberrometry: 30 consecutive LASIK candidates with myopia and regular astigmatism who agree to participate in the study will have up to 4 aberrometry scans acquired consecutively using the Peramis (test) aberrometer.
Peramis aberrometry
A non-invasive photographic scan sequence acquired in under 10 seconds
Myopia (iDesign)
iDesign aberrometry: The same 30 consecutive LASIK candidates scanned in the Myopia (Peramis) arm will also have up to 4 aberrometry scans acquired consecutively using the iDesign aberrometer (control) aberrometer. The order of scans (Peramis and iDesign) will be randomised.
iDesign aberrometry
A non-invasive photographic scan sequence acquired in under 10 seconds
Irregular astigmatism (Peramis)
Peramis aberrometry: 30 consecutive cases with stage II-III keratoconus or post corneal transplantation cases with irregular astigmatism will have up to 4 aberrometry scans acquired consecutively using the Peramis (test) aberrometer
Peramis aberrometry
A non-invasive photographic scan sequence acquired in under 10 seconds
Irregular astigmatism (iDesign)
iDesign aberrometry: 30 consecutive cases with stage II-III keratoconus or post corneal transplantation cases with irregular astigmatism will also have up to 4 aberrometry scans acquired consecutively using the iDesign aberrometer (control) aberrometer. The order of scans (Peramis and iDesign) will be randomised.
iDesign aberrometry
A non-invasive photographic scan sequence acquired in under 10 seconds
Interventions
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Peramis aberrometry
A non-invasive photographic scan sequence acquired in under 10 seconds
iDesign aberrometry
A non-invasive photographic scan sequence acquired in under 10 seconds
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unable to complete a sequence of 2 good scans (acquisition diameter \>5mm) in one eye within 4 attempts
21 Years
60 Years
ALL
No
Sponsors
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Moorfields Eye Hospital NHS Foundation Trust
OTHER
Responsible Party
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Bruce Allan
Consultant Ophthalmic Surgeon
Principal Investigators
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Bruce Allan, MD FRCOphth
Role: PRINCIPAL_INVESTIGATOR
Moorfields Eye Hospital NHS Foundation Trust
Central Contacts
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References
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Visser N, Berendschot TT, Verbakel F, Tan AN, de Brabander J, Nuijts RM. Evaluation of the comparability and repeatability of four wavefront aberrometers. Invest Ophthalmol Vis Sci. 2011 Mar 10;52(3):1302-11. doi: 10.1167/iovs.10-5841.
LeDue J, Jolissaint L, Veran JP, Bradley C. Calibration and testing with real turbulence of a pyramid sensor employing static modulation. Opt Express. 2009 Apr 27;17(9):7186-95. doi: 10.1364/oe.17.007186.
Cagigal MP, Valle PJ. Wavefront sensing using diffractive elements. Opt Lett. 2012 Sep 15;37(18):3813-5. doi: 10.1364/ol.37.003813.
Jung JW, Chung BH, Han SH, Kim EK, Seo KY, Kim TI. Comparison of Measurements and Clinical Outcomes After Wavefront-Guided LASEK Between iDesign and WaveScan. J Refract Surg. 2015 Jun;31(6):398-405. doi: 10.3928/1081597X-20150521-06.
Other Identifiers
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ALLB1019
Identifier Type: -
Identifier Source: org_study_id
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