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

June 14, 2016 updated by: European Vision Institute Clinical Research Network
The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1646

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03016
        • VISSUM - Instituto Oftalmológico de Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Normal subjects

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal subjects
Subjects with two normal eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
19 months
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).
19 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 30, 2010

First Posted (ESTIMATE)

August 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECR-CCRS-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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