Corneal OpacityNCT00439114
Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze
An observational study of Corneal Opacity, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained. Read more about this study
- Who is it for?
- Ages 18 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Opacity
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2005to Jun 2006
- 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 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with significant corneal haze on slit-lamp are included in the study group. 50 eyes of 50 age-matched patients with normal eye and clear cornea are included in the control group. Only one eye of each subject is included.
Who cannot join
- Exclusion criteria to participate in the study are previous ocular surgery, history of contact lens use, glaucoma, and topical ocular medication use, excluding artificial tears.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University, Faculty of Medicine, Adana Hospital
Adana, 01250
About this study
This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis.
Read the detailed description
We planned this study to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. In this institutional based, prospective, controlled clinical trial subjects with corneal haze not related to surgery are included. Normal eyes are used as control group to calculate the customized acoustic factor. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained by one technician each masked to the other measurement. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis. According to the results of the study, we will determine which method is accurate in subjects with corneal haze.
- Conditions
- Corneal Opacity
- Keywords
- Corneal topography, corneal opacity, keratitis, trachoma
- Medical subject headings
- Corneal Opacity, Keratitis, Trachoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startJul 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corneal OpacityStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Rana Altan-Yaycioglu, M.D., Principal investigator, Baskent University, Faculty of Medicine, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439114
- Sponsor's protocol ID
- KA05/207
- Status last verified
- Feb 2007
- First submitted
- 21 Feb 2007
- Last updated
- 23 Feb 2007
- Results posted
- No
Publications
Boscia F, La Tegola MG, Alessio G, Sborgia C. Accuracy of Orbscan optical pachymetry in corneas with haze. J Cataract Refract Surg. 2002 Feb;28(2):253-8. doi: 10.1016/s0886-3350(01)01162-2.
PubMed 11821206Iskander NG, Anderson Penno E, Peters NT, Gimbel HV, Ferensowicz M. Accuracy of Orbscan pachymetry measurements and DHG ultrasound pachymetry in primary laser in situ keratomileusis and LASIK enhancement procedures. J Cataract Refract Surg. 2001 May;27(5):681-5. doi: 10.1016/s0886-3350(01)00820-3.
PubMed 11377895Altan-Yaycioglu R, Pelit A, Akova YA. Comparison of ultrasonic pachymetry with Orbscan in corneal haze. Graefes Arch Clin Exp Ophthalmol. 2007 Dec;245(12):1759-63. doi: 10.1007/s00417-007-0578-5. Epub 2007 Jun 22.
PubMed 17583820
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze
- ClinicalTrials.gov ID
- NCT00439114
- Acronym / sponsor ID
- KA05/207
- Conditions
- Corneal Opacity
- Keywords
- Corneal topography, corneal opacity, keratitis, trachoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jun 2006
- First posted
- 23 Feb 2007 (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.
This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis.
Detailed description
We planned this study to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. In this institutional based, prospective, controlled clinical trial subjects with corneal haze not related to surgery are included. Normal eyes are used as control group to calculate the customized acoustic factor. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained by one technician each masked to the other measurement. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis. According to the results of the study, we will determine which method is accurate in subjects with corneal haze.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with significant corneal haze on slit-lamp are included in the study group. 50 eyes of 50 age-matched patients with normal eye and clear cornea are included in the control group. Only one eye of each subject is included.
Key exclusion criteria (1 listed)
- Exclusion criteria to participate in the study are previous ocular surgery, history of contact lens use, glaucoma, and topical ocular medication use, excluding artificial tears.
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
Not reported in the source record.
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 23 Feb 2007.
- Background: PubMed 11821206Boscia F, La Tegola MG, Alessio G, Sborgia C. Accuracy of Orbscan optical pachymetry in corneas with haze. J Cataract Refract Surg. 2002 Feb;28(2):253-8. doi: 10.1016/s0886-3350(01)01162-2.
- Background: PubMed 11377895Iskander NG, Anderson Penno E, Peters NT, Gimbel HV, Ferensowicz M. Accuracy of Orbscan pachymetry measurements and DHG ultrasound pachymetry in primary laser in situ keratomileusis and LASIK enhancement procedures. J Cataract Refract Surg. 2001 May;27(5):681-5. doi: 10.1016/s0886-3350(01)00820-3.
- Derived from this study: PubMed 17583820Altan-Yaycioglu R, Pelit A, Akova YA. Comparison of ultrasonic pachymetry with Orbscan in corneal haze. Graefes Arch Clin Exp Ophthalmol. 2007 Dec;245(12):1759-63. doi: 10.1007/s00417-007-0578-5. Epub 2007 Jun 22.
Related trials for Corneal Opacity
Active, not recruiting
Clinical Outcomes of the Gore Synthetic Cornea Device
Corneal Opacity
Recruiting
Losartan for Corneal Fibrosis
Corneal Scarring Fibrosis
Recruiting
PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus
Keratoconus
RecruitingObservational study
OCT in Diagnosis of Irregular Corneas
Keratoconus, Corneal Opacity
RecruitingObservational study
Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema
Corneal Diseases, Corneal Scars and Opacities
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.
Rana Altan-Yaycioglu, M.D. principal investigator
Baskent University, Faculty of Medicine, Department of Ophthalmology
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 Opacity, run by Baskent University at 1 site in Turkey (Türkiye).
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 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 23 Feb 2007. 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 Turkey (Türkiye). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00439114, which also lists 3 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 23 Feb 2007.