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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01173614
First Posted: August 2, 2010
Last Update Posted: June 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
European Vision Institute Clinical Research Network
  Purpose
The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.

Condition
Normal Subjects, Ametropia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes

Resource links provided by NLM:


Further study details as provided by European Vision Institute Clinical Research Network:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 1646
Study Start Date: January 2011
Study Completion Date: June 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal subjects
Subjects with two normal eyes.

  Eligibility

Information from the National Library of Medicine

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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).
  Contacts and Locations
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
  More Information

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 Submitted: July 28, 2010
First Posted: August 2, 2010
Last Update Posted: June 15, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases