Refractive ErrorsNCT02687022
Measurement Repeatability in Contemporary Aberrometry
A study testing Peramis aberrometry and iDesign aberrometry in people with Refractive Errors, run by Moorfields Eye Hospital NHS Foundation Trust.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Peramis aberrometry and iDesign aberrometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2016
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Study of Measurement Repeatability for Two Aberrometers
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.
Read the detailed description
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
- Refractive Errors
- Being tested
- Peramis aberrometry, iDesign aberrometry
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peramis aberrometryDevice
Also called Wavefront scanning
A non-invasive photographic scan sequence acquired in under 10 seconds
iDesign aberrometryDevice
Also called Wavefront scanning
A non-invasive photographic scan sequence acquired in under 10 seconds
| Study group | Role | What they receive |
|---|---|---|
| Myopia (Peramis) | Experimental | 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. Receives: Device: Peramis aberrometry |
| Myopia (iDesign) | Active comparator | 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. Receives: Device: iDesign aberrometry |
| Irregular astigmatism (Peramis) | Experimental | 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 Receives: Device: Peramis aberrometry |
| Irregular astigmatism (iDesign) | Active comparator | 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. Receives: Device: iDesign aberrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
2nd to 4th order aberrations (5mm pupil).
M, J0, J45, Coma, Trefoil, Spherical Aberration. Different types of defocus or aberration can be defined and measured by wavefront scanning. Aberrations are classified and quantified by a mathematical treatment called Zernike analysis in which harmonic elements of the waveform of the light detected by the wavefront sensor (aberrometer) are quantified in sequence, starting with simple (lower order) waveforms such as sphere and cylinder (M, J0, J45) corrected in a normal spectacle prescription, and progressing through more complex (higher order) waveforms including, coma, trefoil and spherical aberration which may influence quality of vision. The amount of each aberration varies as a function of pupil size. So pupil size is standardised at 5mm diameter for quantification.
Measured: <10 seconds
Secondary outcomes (1)
% of patients with qualifying scan sequence
% of patients in whom two 5mm diameter aberrometry scans can be acquired within 4 attempts
Measured: <5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Allan, Moorfields Eye Hospital NHS Foundation Trust
- Investigators
- Bruce Allan, MD FRCOphth, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687022
- Sponsor's protocol ID
- ALLB1019
- Status last verified
- Feb 2016
- First submitted
- 7 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators plan to publish summary descriptive data and analyses. Anonymised individual data will be available to systematic reviewers on request.
Publications
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.
PubMed 21051697LeDue 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.
PubMed 19399094Cagigal MP, Valle PJ. Wavefront sensing using diffractive elements. Opt Lett. 2012 Sep 15;37(18):3813-5. doi: 10.1364/ol.37.003813.
PubMed 23041868Jung 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.
PubMed 26046707
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Measurement Repeatability for Two Aberrometers
- ClinicalTrials.gov ID
- NCT02687022
- Acronym / sponsor ID
- ALLB1019
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 22 Feb 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.
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
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Myopia (Peramis) | Experimental | Device: Peramis aberrometryPeramis 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. |
| Myopia (iDesign) | Active comparator | Device: iDesign aberrometryiDesign 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. |
| Irregular astigmatism (Peramis) | Experimental | Device: Peramis aberrometryPeramis 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 |
| Irregular astigmatism (iDesign) | Active comparator | Device: iDesign aberrometryiDesign 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Peramis aberrometryAlso: Wavefront scanningA non-invasive photographic scan sequence acquired in under 10 seconds | Device | Irregular astigmatism (Peramis), Myopia (Peramis) |
| iDesign aberrometryAlso: Wavefront scanningA non-invasive photographic scan sequence acquired in under 10 seconds | Device | Irregular astigmatism (iDesign), Myopia (iDesign) |
Primary outcome
2nd to 4th order aberrations (5mm pupil).
Time frame: <10 seconds
M, J0, J45, Coma, Trefoil, Spherical Aberration. Different types of defocus or aberration can be defined and measured by wavefront scanning. Aberrations are classified and quantified by a mathematical treatment called Zernike analysis in which harmonic elements of the waveform of the light detected by the wavefront sensor (aberrometer) are quantified in sequence, starting with simple (lower order) waveforms such as sphere and cylinder (M, J0, J45) corrected in a normal spectacle prescription, and progressing through more complex (higher order) waveforms including, coma, trefoil and spherical aberration which may influence quality of vision. The amount of each aberration varies as a function of pupil size. So pupil size is standardised at 5mm diameter for quantification.
1 secondary outcome
% of patients with qualifying scan sequence
Time frame: <5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Background: PubMed 21051697Visser 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.
- Background: PubMed 19399094LeDue 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.
- Background: PubMed 23041868Cagigal MP, Valle PJ. Wavefront sensing using diffractive elements. Opt Lett. 2012 Sep 15;37(18):3813-5. doi: 10.1364/ol.37.003813.
- Background: PubMed 26046707Jung 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.
- Individual participant dataSharing planned: Yes. The investigators plan to publish summary descriptive data and analyses. Anonymised individual data will be available to systematic reviewers on request.
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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.
Bruce Allan, MD FRCOphth principal investigator
Moorfields Eye Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Peramis aberrometry and iDesign aberrometry in people with Refractive Errors, run by Moorfields Eye Hospital NHS Foundation Trust.
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 1 inclusion and 2 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Angelique Thomas (02075662156, angelique.thomas@moorfields.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2nd to 4th order aberrations (5mm pupil). (time frame: <10 seconds). 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 NCT02687022, which also lists 4 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 22 Feb 2016.