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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01173614

Acronym

Gullstrand

Enrollment

1646

Registered

2010-08-02

Start date

2011-01-31

Completion date

2016-06-30

Last updated

2016-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Subjects, Ametropia

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results