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

Completed

• Conditions: Normal Subjects, Ametropia

• Registration Number: NCT01173614
• Lead Sponsor: European Vision Institute Clinical Research Network

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-30
• Study First Posted: 2010-08-02
• Study Start: 2011-01
• Primary Completion: 2015-06
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1646

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

VISSUM - Instituto Oftalmológico de Alicante; 🇪🇸 Alicante, Spain