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

European Vision Institute Clinical Research Network1,646 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,646

Conditions

Normal Subjects, Ametropia

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

VISSUM - Instituto Oftalmológico de Alicante

Alicante, Spain, Spain

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 19 months

Secondary Outcomes

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.

Time frame: 19 Months

Data from ClinicalTrials.gov

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