Normal Subjects, AmetropiaGullstrandNCT01173614
Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes
An observational study of Normal Subjects, Ametropia, run by European Vision Institute Clinical Research Network at 1 site in Spain.
Trial summary
The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Normal Subjects, Ametropia
- How many people
- 1,646 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Jun 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Normal subjects
Who may be able to join
- Two normal eyes
- Ametropia between -10D and +10D.
Who cannot join
- One pathological eye
- Prior ocular surgery
- Amblyopia, refraction larger than ±10D
- Corneal or retinal pathologies
- Systemic diseases (e.g. diabetes, multiple sclerosis, …)
- More than 5 months pregnant at the moment of testing
- Recent wear of hard contact lenses
- Epilepsy (if C-Quant is used).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.
- Conditions
- Normal Subjects, Ametropia
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Subjects with two normal eyes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to obtain a predetermined number of valid ocular biometry measurements per participating site
The test that will be performed are the eye dominance, uncorrected and corrected distance visual acuity (UDVA and CDVA), (accommodation, ocular refraction (automatic refraction), spectacle refraction, axial length (optical, ultrasound), anterior segment biometry (anterior chamber depth), corneal topography (keratometry), contrast sensitivity (Pelli-Robson/ Sine Wave Contrast Test (SWCT), pupil size (gauge)), intraocular pressure, the VFQ-25 questionnaire and some demographic data (age, gender, ethnicity, eye color, highest education).
Measured: 19 months
To obtain a predetermined number of valid visual function measurements per participating site
The tests that will be performed are the eye dominance, accommodation, uncorrected and spectacle corrected visual acuity (UCVA and SCVA), ocular refraction (automatic refraction), spectacle refraction, axial length (optical, ultrasound), anterior segment biometry (anterior chamber depth), corneal topography (keratometry), contrast sensitivity (Pelli-Robson/ Sine Wave Contrast Test (SWCT)), intraocular pressure, the VFQ-25 questionnaire and some demographic data (age, gender, ethnicity, eye color, highest education).
Measured: 19 months
Secondary outcomes (1)
Provide a reference database for research purposes
Protocol foresees in inclusion optional tests:straylight measurement (using Oculus C-Quant,pupillometry,distance-corrected intermediate and near visual acuity(DCIVA and DCNVA,crystalline lens thickness,aberrometry,ORA measurements (IOPcc,IOPG,CRF,CH parameters.These tests may be added by the individual sites depending of the availability of equipment.A number of secondary parameters can also be derived from primary parameters using calculations (e.g.crystalline lens power, estimated aniseikonia,etc) or by analysis of the raw data of computer based tests.
Measured: 19 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Subjects, AmetropiaStudies 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
- 1,646 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Vision Institute Clinical Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jos Rozema, MSc PhD, Study chair, Dept of Ophthalmology, Antwerp University Hospital. Edegem, BelgiumMarie-José Tassignon, MD PhD, Principal investigator, Dept of Ophthalmology, Antwerp University Hospital. Edegem, BelgiumSotiris Plainis, MSc PhD, Principal investigator, Institute of Vision and Optics (IVO), University of Crete, School of Health Sciences, Heraklion Crete, Greece 71003
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173614
- Sponsor's protocol ID
- ECR-CCRS-2010-01
- Acronym
- Gullstrand
- Status last verified
- Jun 2016
- First submitted
- 28 Jul 2010
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zocher MT, Rozema JJ, Oertel N, Dawczynski J, Wiedemann P, Rauscher FG; EVICR.net. Biometry and visual function of a healthy cohort in Leipzig, Germany. BMC Ophthalmol. 2016 Jun 7;16:79. doi: 10.1186/s12886-016-0232-2.
PubMed 27268271
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes
- ClinicalTrials.gov ID
- NCT01173614
- Acronym / sponsor ID
- Gullstrand / ECR-CCRS-2010-01
- Conditions
- Normal Subjects, Ametropia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,646 participants (actual)
- Lead sponsor
- European Vision Institute Clinical Research NetworkResearch network
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Aug 2010 (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 the average values of human ocular biometry and to correlate these values with visual function.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | – | –Subjects with two normal eyes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Normal subjects
Key inclusion criteria (2 listed)
- Two normal eyes
- Ametropia between -10D and +10D.
Key exclusion criteria (8 listed)
- One pathological eye
- Prior ocular surgery
- Amblyopia, refraction larger than ±10D
- Corneal or retinal pathologies
- Systemic diseases (e.g. diabetes, multiple sclerosis, …)
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
to obtain a predetermined number of valid ocular biometry measurements per participating site
Time frame: 19 months
The test that will be performed are the eye dominance, uncorrected and corrected distance visual acuity (UDVA and CDVA), (accommodation, ocular refraction (automatic refraction), spectacle refraction, axial length (optical, ultrasound), anterior segment biometry (anterior chamber depth), corneal topography (keratometry), contrast sensitivity (Pelli-Robson/ Sine Wave Contrast Test (SWCT), pupil size (gauge)), intraocular pressure, the VFQ-25 questionnaire and some demographic data (age, gender, ethnicity, eye color, highest education).
To obtain a predetermined number of valid visual function measurements per participating site
Time frame: 19 months
The tests that will be performed are the eye dominance, accommodation, uncorrected and spectacle corrected visual acuity (UCVA and SCVA), ocular refraction (automatic refraction), spectacle refraction, axial length (optical, ultrasound), anterior segment biometry (anterior chamber depth), corneal topography (keratometry), contrast sensitivity (Pelli-Robson/ Sine Wave Contrast Test (SWCT)), intraocular pressure, the VFQ-25 questionnaire and some demographic data (age, gender, ethnicity, eye color, highest education).
1 secondary outcome
Provide a reference database for research purposes
Time frame: 19 Months
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 15 Jun 2016.
- Derived from this study: PubMed 27268271Zocher MT, Rozema JJ, Oertel N, Dawczynski J, Wiedemann P, Rauscher FG; EVICR.net. Biometry and visual function of a healthy cohort in Leipzig, Germany. BMC Ophthalmol. 2016 Jun 7;16:79. doi: 10.1186/s12886-016-0232-2.
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.
Jos Rozema, MSc PhD study chair
Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium
Marie-José Tassignon, MD PhD principal investigator
Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium
Sotiris Plainis, MSc PhD principal investigator
Institute of Vision and Optics (IVO), University of Crete, School of Health Sciences, Heraklion Crete, Greece 71003
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 Normal Subjects, Ametropia, run by European Vision Institute Clinical Research Network at 1 site in Spain.
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 2 inclusion and 8 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 15 Jun 2016. 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 Spain. 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?
to obtain a predetermined number of valid ocular biometry measurements per participating site (time frame: 19 months). The study lists 2 primary outcomes in all. 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 NCT01173614, which also lists 1 linked publication.
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 15 Jun 2016.