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

NCT ID: NCT01173614

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1646 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.

Detailed Description

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Conditions

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Normal Subjects, Ametropia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Normal subjects

Subjects with two normal eyes.

No interventions assigned to this group

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Vision Institute Clinical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jos Rozema, MSc PhD

Role: STUDY_CHAIR

Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium

Marie-José Tassignon, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Ophthalmology, Antwerp University Hospital. Edegem, Belgium

Sotiris Plainis, MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Vision and Optics (IVO), University of Crete, School of Health Sciences, Heraklion Crete, Greece 71003

Locations

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VISSUM - Instituto Oftalmológico de Alicante

Alicante, Spain, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 27268271 (View on PubMed)

Other Identifiers

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ECR-CCRS-2010-01

Identifier Type: -

Identifier Source: org_study_id

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