Corneal TopographyNCT01861925

Study of Clinical Performance of Corneal Topography Measurement Using an Optical Biometer

An observational study of Corneal Topography, run by Haag-Streit AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Corneal Topography
How many people: 50 participants
Where: 1 siteSwitzerland
Study dates: Jun 2013to Jul 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Volunteers recruited at University Hospital

Who may be able to join

18 years or older

Who cannot join

No corneal transplants
No corneal scar(s)
No acute infections of the eye
No weak fixation
No suspected lack of compliance
No vulnerable population

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital Inselspital
Bern, 3010

Other trials in Switzerland

About this study

Official title: Lenstar LS 900 Topography

Conditions: Corneal Topography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01861925
Study group	Role	What they receive
Normal eye		Astigmatism smaller than 1.5 diopters
Large regular astigmatism		Astigmatism of > 1.5 diopters, regular astigmatism.
Large irregular astigmatism		Astigmatism of > 1.5 diopters, irregular astigmatism.

What is being measured

The primary outcome is the main question the study is designed to answer.

In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements
Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. "Diopter" is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R.
Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination.
According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm<d<=6mm.
"power difference (2 rep. meas.)": sample mean and 95% C.I. of differences of spatial mean of corneal power between two consecutive measurements.
"power difference 2 std.dev.": sample mean of twice the deviation of local power differences (two consecutive measurements).
Measured: 1 day of examination

Secondary outcomes (1)

Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device.
For definition of corneal topography, corneal power in "diopter", areas of evaluation and methods, see outcome 1.
This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.
"power difference (2 devices)" is the sample mean and 95% C.I. of differences of spatial mean of corneal power between two devices. This value quantifies systematic differences between devices (e.g. calibration), ignoring local variations of the power measurement.
"power difference (2 std.dev.)" is the sample mean of twice the standard deviation of local power differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices.
Measured: 1 day of examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jul 2013

First posted24 May 2013 (estimated)
Study startJun 2013
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Corneal TopographyStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01861925
Sponsor's protocol ID: HS-LS900-TOPO-01
Status last verified: May 2014
First submitted: 21 May 2013
Last updated: 5 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Corneal Topography trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lenstar LS 900 Topography
ClinicalTrials.gov ID: NCT01861925
Acronym / sponsor ID: HS-LS900-TOPO-01
Conditions: Corneal Topography
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Haag-Streit AGIndustry (pharma, biotech, devices)
Collaborators: Insel Gruppe AG, University Hospital Bern
Study start: Jun 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 24 May 2013 (estimated)
Results: Posted 5 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Normal eye	–	–Astigmatism smaller than 1.5 diopters
Large regular astigmatism	–	–Astigmatism of > 1.5 diopters, regular astigmatism.
Large irregular astigmatism	–	–Astigmatism of > 1.5 diopters, irregular astigmatism.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Volunteers recruited at University Hospital

Key inclusion criteria (1 listed)

18 years or older

Key exclusion criteria (6 listed)

No corneal transplants
No corneal scar(s)
No acute infections of the eye
No weak fixation
No suspected lack of compliance

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements
Time frame: 1 day of examination
Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. "Diopter" is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R. Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination. According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm<d<=6mm. "power difference (2 rep. meas.)": sample mean and 95% C.I. of differences of spatial mean of corneal power between two consecutive measurements. "power difference 2 std.dev.": sample mean of twice the deviation of local power differences (two consecutive measurements).

1 secondary outcome

Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device.
Time frame: 1 day of examination

Results and safety

Results posted to the registry on 5 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Eye	34	34
Large Regular Astigmatism	8	8
Large Irregular Astigmatism	8	8

Primary outcome: In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements

Time frame: 1 day of examination. Mean (95% Confidence Interval). Unit: diopters

Measure	Normal Eye n = 34	Large Regular Astigmatism n = 8	Large Irregular Astigmatism n = 8
power difference (2 rep. meas.), central cornea	-0.014 (-0.062 to 0.034)	0.053 (-0.061 to 0.167)	-0.120 (-0.392 to 0.153)
power difference (2 rep. meas.), middle cornea	-0.029 (-0.090 to 0.033)	0.015 (-0.149 to 0.179)	-0.089 (-0.351 to 0.174)
power difference (2 std.dev.), central cornea	0.77 (NA to NA)	0.74 (NA to NA)	1.36 (NA to NA)
power difference (2 std.dev.), middle cornea	0.72 (NA to NA)	0.69 (NA to NA)	1.06 (NA to NA)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Eye	0 of 34 (0%)	0 of 34 (0%)	Not reported
Large Regular Astigmatism	0 of 8 (0%)	0 of 8 (0%)	Not reported
Large Irregular Astigmatism	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Corneal Topography

Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus
Keratoconus
Recruiting
CONTOURA vs WFO Ablation PRK & LASIK
Refractive Surgery
Active, not recruitingObservational study
Predicting Manifest Astigmatism in Keratoconus Patients.
Keratoconus, Keratoconus, Artificial Intelligence, Support Vector Machine
RecruitingObservational study
The Effect of Upper Blepharoplasty on Vision Quality in the Early Postoperative Period
Excess Skin of Both Eyelids, Contrast Sensitivity

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.

Beatrice Frueh, Prof. Fr. principal investigator

Insel Gruppe AG, University Hospital Bern

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 Corneal Topography, run by Haag-Streit AG at 1 site in Switzerland.

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 6 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: finished, as of the sponsor's last update on 5 Jun 2014. 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 Switzerland. 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?

Yes. Results are posted in the registry (first posted 5 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements (time frame: 1 day of examination). 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 NCT01861925.

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 5 Jun 2014.