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

Study Overview
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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.

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

Conditions
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Normal Subjects, Ametropia

Participation Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal subjects<br>Subjects with two normal eyes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provide a reference database for research purposes | 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 |