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

This study is currently recruiting participants.
Verified December 2012 by European Vision Institute Clinical Research Network
Sponsor:
Information provided by:
European Vision Institute Clinical Research Network
ClinicalTrials.gov Identifier:
NCT01173614
First received: July 28, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal subjects
Subjects with two normal eyes.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173614

Contacts
Contact: Cecília Martinho, BSc +351239480104 ext 101 cvm@aibili.pt
Contact: Rita Fernandes, BSc +351239480101 ext 104 anarf@aibili.pt

Locations
Spain
VISSUM - Instituto Oftalmológico de Alicante Recruiting
Alicante, Spain, 03016
Contact: Rita Fernandes, BSc     +351 239480101     anarf@aibili.pt    
Principal Investigator: Jorge Alió, MSc PhD            
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

No publications provided

Responsible Party: Jos Rozema MSc, PhD, Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium
ClinicalTrials.gov Identifier: NCT01173614     History of Changes
Other Study ID Numbers: ECR-CCRS-2010-01
Study First Received: July 28, 2010
Last Updated: December 11, 2012
Health Authority: European Union: European Medicines Agency
Portugal: Ethics Committee for Clinical Research

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013