CataractNCT00494390
Evaluation Study for a Non-Contact Biometer
An observational study of Cataract and Pseudophakia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Pseudophakia, Myopia
- How many people
- 95 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2007to Mar 2008
- 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
Who may be able to join
- 18 year or older
- Normal eye
- Cataract
- Corneal abnormality (scar, opacity, transplant)
- refractive corneal surgery
- Pseudophakia
Show all 10Show fewer
- Aphakia
- Silicon oil
- refractive IOL
- 2.-9. (at least one yes)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ophthalmology, University Hospital
Bern, 3010
About this study
Official title: Neuartige Kontaktlose Biometrische Messungen
The purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard.
Read the detailed description
The features of a not yet commercial available new biometer will be compared to available contact and non contact biometers in different patient groups.
- Conditions
- Cataract, Pseudophakia, Myopia, Hyperopia, Aphakia
- Keywords
- Biometry, corneal opacity, astigmatism, refraction
- Medical subject headings
- Cataract, Pseudophakia, Myopia, Hyperopia, Aphakia, Corneal Opacity, Astigmatism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Haag-Streit AG
- Investigators
- David Goldblum, MD, Principal investigator, www.insel.ch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494390
- Sponsor's protocol ID
- kek-98/07
- Other IDs
- Insel 1351
- Status last verified
- Jul 2007
- First submitted
- 27 Jun 2007
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuartige Kontaktlose Biometrische Messungen
- ClinicalTrials.gov ID
- NCT00494390
- Acronym / sponsor ID
- kek-98/07
- Conditions
- Cataract, Pseudophakia, Myopia, Hyperopia, Aphakia
- Keywords
- Biometry, corneal opacity, astigmatism, refraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Haag-Streit AG
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- First posted
- 29 Jun 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.
The purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard.
Detailed description
The features of a not yet commercial available new biometer will be compared to available contact and non contact biometers in different patient groups.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 year or older
- Normal eye
- Cataract
- Corneal abnormality (scar, opacity, transplant)
- refractive corneal surgery
Key exclusion criteria (0 listed)
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 19 Mar 2008.
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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.
David Goldblum, MD principal investigator
www.insel.ch
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 Cataract and Pseudophakia, run by Insel Gruppe AG, University Hospital Bern 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 10 inclusion and 0 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 19 Mar 2008. 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?
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?
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 19 Mar 2008.