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

Sponsor

European Vision Institute Clinical Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01173614

Collaborator

(none)

1,646

Enrollment

Location

Duration (Months)

25.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Normal Subjects, Ametropia

Study Design

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 :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Normal subjects Subjects with two normal eyes.

Outcome Measures

Primary Outcome Measures

to obtain a predetermined number of valid ocular biometry measurements per participating site [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

European Vision Institute Clinical Research Network

ClinicalTrials.gov Identifier:

NCT01173614

Other Study ID Numbers:

ECR-CCRS-2010-01

First Posted:

Aug 2, 2010

Last Update Posted:

Jun 15, 2016

Last Verified:

Jun 1, 2016

Additional relevant MeSH terms:

Refractive Errors

Study Results

No Results Posted as of Jun 15, 2016