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Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes (Gullstrand)

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ClinicalTrials.gov Identifier: NCT01173614
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
European Vision Institute Clinical Research Network

Brief Summary:
The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.

Condition or disease
Normal Subjects, Ametropia

Study Type : Observational
Actual Enrollment : 1646 participants
Time Perspective: Prospective
Official Title: Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes
Study Start Date : January 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016

Group/Cohort
Normal subjects
Subjects with two normal eyes.



Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Provide a reference database for research purposes [ Time Frame: 19 Months ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Normal subjects
Criteria

Inclusion Criteria:

  • Two normal eyes
  • Ametropia between -10D and +10D.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173614


Locations
Spain
VISSUM - Instituto Oftalmológico de Alicante
Alicante, Spain, 03016
Sponsors and Collaborators
European Vision Institute Clinical Research Network
Investigators
Study Chair: Jos Rozema, MSc PhD Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium
Principal Investigator: Marie-José Tassignon, MD PhD Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium
Principal Investigator: Sotiris Plainis, MSc PhD Institute of Vision and Optics (IVO), University of Crete, School of Health Sciences, Heraklion Crete, Greece 71003

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Vision Institute Clinical Research Network
ClinicalTrials.gov Identifier: NCT01173614     History of Changes
Other Study ID Numbers: ECR-CCRS-2010-01
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases