KeratoconusNCT03511495
Reliability of Topography Measurements in Keratoconus
An observational study of Keratoconus, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the reliability and repeatability of the parameters obtained using the Galilei dual-scheimpflug corneal topographer for monitoring progression in eyes with keratoconus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Galilei Corneal Topographer
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 31 Mar 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective study of patients seen at the Penn State Eye Center who have been diagnosed with keratoconus and are undergoing Galilei corneal topography. Patients will be selected to participate in the study based on inclusion/exclusion criteria. Each patient in the study will undergo five consecutive corneal topography measurements per keratoconic eye.
Who may be able to join
- Patientswho are older than 18 years of age
- Patients who are scheduled to undergo Galilei dual-scheimpflug corneal topography testing
- Patients who have been diagnosed with keratoconus
- Measurements with a reported reliability of 'good' from the topographer
Who cannot join
- Patients who have undergone any prior surgical intervention involving the cornea (i.e. cornea transplant or INTACS, or corneal cross linking)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Eye Center
Hershey, Pennsylvania, 17033
About this study
Official title: Repeatability and Reliability of Galilei Corneal Topographer Measurements in Keratoconus
The purpose of this study is to assess the reliability and repeatability of the parameters obtained using the Galilei dual-scheimpflug corneal topographer for monitoring progression in eyes with keratoconus.
Read the detailed description
Keratoconus is a progressive corneal degeneration characterized by progressive steepening and thinning of the central or paracentral cornea leading to corneal protrusion and resulting irregular astigmatism and high myopia. This disorder is usually bilateral and is linked to atopy and excessive eye rubbing, although the precise pathophysiology behind development of this condition is unclear. Keratoconus is the most common corneal degeneration in the United States, affecting between 50 and 230 subjects per 100,000 population.
Early diagnosis and appropriate management of keratoconus relies greatly on accurate assessment of corneal topographic measurements. It is therefore imperative that the data obtained via corneal topography devices is accurate and reliable.
The GALILEI Dual Scheimpflug Analyzer integrates Placido disc topography and dual Scheimpflug tomography to assess anterior and posterior corneal curvature data. Although there have been several studies performed assessing the ability of the Galilei to accurately distinguish keratoconus from unaffected eyes and investigating interdevice reliability between the Galilei analyzer and other tomographers, to our knowledge the repeatability of measurements obtained in this population via the Galilei device has been incompletely evaluated to date.
Corneal topography data obtained via the Galilei device is relied upon heavily in clinical decision making for keratoconic patients both in the Hershey Eye Clinic and in a great number of ophthalmology practices world-wide. It is vital that the accuracy and repeatability of these measurements obtained via the Galilei device are investigated.
The primary endpoint to be measured in the study will be the maximum (steepest) and minimum (flattest) keratometry values in the central zone.
Secondary endpoints will be maximum keratometry across the entire area scanned, axis of corneal astigmatism, anterior and posterior best fit spheres in float mode with the diameter set to 8 mm, maximum anterior and posterior elevations, thinnest corneal thickness, and corneal asphericity at 6 mm, root mean square (RMS) of the HOAs, RMS of the third-order coma, coma axis, vertical and horizontal coma and spherical aberration.
- Conditions
- Keratoconus
- Being tested
- Galilei Corneal Topographer
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galilei Corneal TopographerDiagnostic test
A series of five measurements via the Galilei corneal topographer of each keratoconic eye in quick succession
| Study group | Role | What they receive |
|---|---|---|
| Keratoconic Patients | Not described Receives: Diagnostic Test: Galilei Corneal Topographer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum (steepest) and minimum (flattest) keratometry values in the central zone
Assessment of the steepness of the cornea
Measured: Measured at day 0 of study enrollment
Secondary outcomes (1)
Thinnest pachymetry
The thinnest area of the cornea
Measured: Measured at day 0 of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start11 Sep 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth M Pantanelli, Milton S. Hershey Medical Center
- Investigators
- Seth Pantanelli, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511495
- Sponsor's protocol ID
- STUDY00007951
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
PubMed 9493273Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. doi: 10.1136/bjo.84.8.834.
PubMed 10906086Demir S, Sonmez B, Yeter V, Ortak H. Comparison of normal and keratoconic corneas by Galilei Dual-Scheimpflug Analyzer. Cont Lens Anterior Eye. 2013 Oct;36(5):219-25. doi: 10.1016/j.clae.2013.04.001. Epub 2013 Apr 30.
PubMed 23642799Holladay JT. Keratoconus detection using corneal topography. J Refract Surg. 2009 Oct;25(10 Suppl):S958-62. doi: 10.3928/1081597X-20090915-11.
PubMed 19848378Guler E, Yagci R, Akyol M, Arslanyilmaz Z, Balci M, Hepsen IF. Repeatability and reproducibility of Galilei measurements in normal keratoconic and postrefractive corneas. Cont Lens Anterior Eye. 2014 Oct;37(5):331-6. doi: 10.1016/j.clae.2014.04.004. Epub 2014 Jun 14.
PubMed 24938125Meyer JJ, Gokul A, Vellara HR, Prime Z, McGhee CN. Repeatability and Agreement of Orbscan II, Pentacam HR, and Galilei Tomography Systems in Corneas With Keratoconus. Am J Ophthalmol. 2017 Mar;175:122-128. doi: 10.1016/j.ajo.2016.12.003. Epub 2016 Dec 18.
PubMed 27993593Feizi S, Yaseri M, Kheiri B. Predictive Ability of Galilei to Distinguish Subclinical Keratoconus and Keratoconus from Normal Corneas. J Ophthalmic Vis Res. 2016 Jan-Mar;11(1):8-16. doi: 10.4103/2008-322X.180707.
PubMed 27195079Jahadi Hosseini HR, Katbab A, Khalili MR, Abtahi MB. Comparison of corneal thickness measurements using Galilei, HR Pentacam, and ultrasound. Cornea. 2010 Oct;29(10):1091-5. doi: 10.1097/ICO.0b013e3181cf98e5.
PubMed 20628301Anayol MA, Guler E, Yagci R, Sekeroglu MA, Ylmazoglu M, Trhs H, Kulak AE, Ylmazbas P. Comparison of central corneal thickness, thinnest corneal thickness, anterior chamber depth, and simulated keratometry using galilei, Pentacam, and Sirius devices. Cornea. 2014 Jun;33(6):582-6. doi: 10.1097/ICO.0000000000000119.
PubMed 24763122Park SH, Choi SK, Lee D, Jun EJ, Kim JH. Corneal thickness measurement using Orbscan, Pentacam, Galilei, and ultrasound in normal and post-femtosecond laser in situ keratomileusis eyes. Cornea. 2012 Sep;31(9):978-82. doi: 10.1097/ICO.0b013e31823d03fc.
PubMed 22699561Crawford AZ, Patel DV, McGhee CN. Comparison and repeatability of keratometric and corneal power measurements obtained by Orbscan II, Pentacam, and Galilei corneal tomography systems. Am J Ophthalmol. 2013 Jul;156(1):53-60. doi: 10.1016/j.ajo.2013.01.029. Epub 2013 Mar 28.
PubMed 23540708
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reliability of Galilei Corneal Topographer Measurements in Keratoconus
- ClinicalTrials.gov ID
- NCT03511495
- Acronym / sponsor ID
- STUDY00007951
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- 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.
The purpose of this study is to assess the reliability and repeatability of the parameters obtained using the Galilei dual-scheimpflug corneal topographer for monitoring progression in eyes with keratoconus.
Detailed description
Keratoconus is a progressive corneal degeneration characterized by progressive steepening and thinning of the central or paracentral cornea leading to corneal protrusion and resulting irregular astigmatism and high myopia. This disorder is usually bilateral and is linked to atopy and excessive eye rubbing, although the precise pathophysiology behind development of this condition is unclear. Keratoconus is the most common corneal degeneration in the United States, affecting between 50 and 230 subjects per 100,000 population.
Early diagnosis and appropriate management of keratoconus relies greatly on accurate assessment of corneal topographic measurements. It is therefore imperative that the data obtained via corneal topography devices is accurate and reliable.
The GALILEI Dual Scheimpflug Analyzer integrates Placido disc topography and dual Scheimpflug tomography to assess anterior and posterior corneal curvature data. Although there have been several studies performed assessing the ability of the Galilei to accurately distinguish keratoconus from unaffected eyes and investigating interdevice reliability between the Galilei analyzer and other tomographers, to our knowledge the repeatability of measurements obtained in this population via the Galilei device has been incompletely evaluated to date.
Corneal topography data obtained via the Galilei device is relied upon heavily in clinical decision making for keratoconic patients both in the Hershey Eye Clinic and in a great number of ophthalmology practices world-wide. It is vital that the accuracy and repeatability of these measurements obtained via the Galilei device are investigated.
The primary endpoint to be measured in the study will be the maximum (steepest) and minimum (flattest) keratometry values in the central zone.
Secondary endpoints will be maximum keratometry across the entire area scanned, axis of corneal astigmatism, anterior and posterior best fit spheres in float mode with the diameter set to 8 mm, maximum anterior and posterior elevations, thinnest corneal thickness, and corneal asphericity at 6 mm, root mean square (RMS) of the HOAs, RMS of the third-order coma, coma axis, vertical and horizontal coma and spherical aberration.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoconic Patients | – | Diagnostic Test: Galilei Corneal Topographer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective study of patients seen at the Penn State Eye Center who have been diagnosed with keratoconus and are undergoing Galilei corneal topography. Patients will be selected to participate in the study based on inclusion/exclusion criteria. Each patient in the study will undergo five consecutive corneal topography measurements per keratoconic eye.
Key inclusion criteria (4 listed)
- Patientswho are older than 18 years of age
- Patients who are scheduled to undergo Galilei dual-scheimpflug corneal topography testing
- Patients who have been diagnosed with keratoconus
- Measurements with a reported reliability of 'good' from the topographer
Key exclusion criteria (1 listed)
- Patients who have undergone any prior surgical intervention involving the cornea (i.e. cornea transplant or INTACS, or corneal cross linking)
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 |
|---|---|---|
| Galilei Corneal TopographerA series of five measurements via the Galilei corneal topographer of each keratoconic eye in quick succession | Diagnostic test | Keratoconic Patients |
Primary outcome
Maximum (steepest) and minimum (flattest) keratometry values in the central zone
Time frame: Measured at day 0 of study enrollment
Assessment of the steepness of the cornea
1 secondary outcome
Thinnest pachymetry
Time frame: Measured at day 0 of study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Background: PubMed 9493273Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
- Background: PubMed 10906086Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. doi: 10.1136/bjo.84.8.834.
- Background: PubMed 23642799Demir S, Sonmez B, Yeter V, Ortak H. Comparison of normal and keratoconic corneas by Galilei Dual-Scheimpflug Analyzer. Cont Lens Anterior Eye. 2013 Oct;36(5):219-25. doi: 10.1016/j.clae.2013.04.001. Epub 2013 Apr 30.
- Background: PubMed 19848378Holladay JT. Keratoconus detection using corneal topography. J Refract Surg. 2009 Oct;25(10 Suppl):S958-62. doi: 10.3928/1081597X-20090915-11.
- Background: PubMed 24938125Guler E, Yagci R, Akyol M, Arslanyilmaz Z, Balci M, Hepsen IF. Repeatability and reproducibility of Galilei measurements in normal keratoconic and postrefractive corneas. Cont Lens Anterior Eye. 2014 Oct;37(5):331-6. doi: 10.1016/j.clae.2014.04.004. Epub 2014 Jun 14.
- Background: PubMed 27993593Meyer JJ, Gokul A, Vellara HR, Prime Z, McGhee CN. Repeatability and Agreement of Orbscan II, Pentacam HR, and Galilei Tomography Systems in Corneas With Keratoconus. Am J Ophthalmol. 2017 Mar;175:122-128. doi: 10.1016/j.ajo.2016.12.003. Epub 2016 Dec 18.
- Background: PubMed 27195079Feizi S, Yaseri M, Kheiri B. Predictive Ability of Galilei to Distinguish Subclinical Keratoconus and Keratoconus from Normal Corneas. J Ophthalmic Vis Res. 2016 Jan-Mar;11(1):8-16. doi: 10.4103/2008-322X.180707.
- Background: PubMed 20628301Jahadi Hosseini HR, Katbab A, Khalili MR, Abtahi MB. Comparison of corneal thickness measurements using Galilei, HR Pentacam, and ultrasound. Cornea. 2010 Oct;29(10):1091-5. doi: 10.1097/ICO.0b013e3181cf98e5.
- Background: PubMed 24763122Anayol MA, Guler E, Yagci R, Sekeroglu MA, Ylmazoglu M, Trhs H, Kulak AE, Ylmazbas P. Comparison of central corneal thickness, thinnest corneal thickness, anterior chamber depth, and simulated keratometry using galilei, Pentacam, and Sirius devices. Cornea. 2014 Jun;33(6):582-6. doi: 10.1097/ICO.0000000000000119.
- Background: PubMed 22699561Park SH, Choi SK, Lee D, Jun EJ, Kim JH. Corneal thickness measurement using Orbscan, Pentacam, Galilei, and ultrasound in normal and post-femtosecond laser in situ keratomileusis eyes. Cornea. 2012 Sep;31(9):978-82. doi: 10.1097/ICO.0b013e31823d03fc.
- Background: PubMed 23540708Crawford AZ, Patel DV, McGhee CN. Comparison and repeatability of keratometric and corneal power measurements obtained by Orbscan II, Pentacam, and Galilei corneal tomography systems. Am J Ophthalmol. 2013 Jul;156(1):53-60. doi: 10.1016/j.ajo.2013.01.029. Epub 2013 Mar 28.
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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.
Seth Pantanelli, MD principal investigator
Milton S. Hershey Medical Center
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 Keratoconus, run by Milton S. Hershey Medical Center at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 22 Apr 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum (steepest) and minimum (flattest) keratometry values in the central zone (time frame: Measured at day 0 of study enrollment). 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 NCT03511495, which also lists 11 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 Apr 2019.