Measurement Repeatability in Contemporary Aberrometry

NCT ID: NCT02687022

Last Updated: 2016-02-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-09-30

Brief Summary

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Wavefront scans are a common form of diagnostic test applied in preparing patients for laser eye surgery. An optical map of the eye is created by wavefront scanning, and information from these maps is used to program lasers used to correct focusing errors in the eye. Here the investigators are comparing how repeatable measurements are with a new wavefront scanner and one that is already in widespread use.

Detailed Description

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Aberrometers are used to measure each element of defocus (aberration) in an optical system. In LASIK, information derived from aberrometry (scans performed using aberrometers) is used to program the pattern of laser pulses delivered by an excimer laser in therapeutic reshaping of the cornea to correct defocus. To do this accurately, aberrometry findings need to be repeatable and correspond closely to manifest refraction. Here the investigators compare repeatability of measurements for a new aberrometer (Peramis) versus the aberrometer most widely used in contemporary wavefront guided laser vision correction (iDesign).

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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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

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.

Group Type EXPERIMENTAL

Peramis aberrometry

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

iDesign aberrometry

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Peramis aberrometry

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

iDesign aberrometry

Intervention Type DEVICE

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

Intervention Type DEVICE

iDesign aberrometry

A non-invasive photographic scan sequence acquired in under 10 seconds

Intervention Type DEVICE

Other Intervention Names

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Wavefront scanning Wavefront scanning

Eligibility Criteria

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Inclusion Criteria

* Myopic LASIK candidates (manifest refraction spherical equivalent range 0 to -10 diopters with up to 6 diopters cylinder) or patients attending corneal service with stage II-III keratoconus or post-keratoplasty

Exclusion Criteria

* Visually significant co-pathology (CDVA\<6/6) other than irregular astigmatism;
* Patients unable to complete a sequence of 2 good scans (acquisition diameter \>5mm) in one eye within 4 attempts
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Bruce Allan

Consultant Ophthalmic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Angelique Thomas

Role: CONTACT

02075662156

Barbara Stacey

Role: CONTACT

02075662320

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.

Reference Type BACKGROUND
PMID: 21051697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19399094 (View on PubMed)

Cagigal MP, Valle PJ. Wavefront sensing using diffractive elements. Opt Lett. 2012 Sep 15;37(18):3813-5. doi: 10.1364/ol.37.003813.

Reference Type BACKGROUND
PMID: 23041868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26046707 (View on PubMed)

Other Identifiers

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ALLB1019

Identifier Type: -

Identifier Source: org_study_id

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