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

NCT01173614 | Completed

• 1 other identifier: ECR-CCRS-2010-01
• Study Type: observational
• Target: 1,646
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Subjects, Ametropia

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  19 months

Secondary Outcomes (1)

• Provide a reference database for research purposes

  19 Months

Study Arms (1)

Normal subjects

Subjects with two normal eyes.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Normal subjects

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• European Vision Institute Clinical Research Network: lead

Study Sites (1)

VISSUM - Instituto Oftalmológico de Alicante

Alicante, Spain, 03016, Spain

Location

Related Publications (1)

• 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.

  PMID: 27268271 DERIVED

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Jos Rozema, MSc PhD

  Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: August 2, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

ES (1)