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Completed

NCT Number: NCT01173614

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

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

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Key information

Conditions

Normal Subjects, Ametropia Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Observational

Primary location

VISSUM - Instituto Oftalmológico de Alicante

Alicante, Spain, 03016

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. to obtain a predetermined number of valid ocular biometry measurements per participating site

    Time frame: 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).

  2. To obtain a predetermined number of valid visual function measurements per participating site

    Time frame: 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 outcomes

  1. Provide a reference database for research purposes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

European Vision Institute Clinical Research Network

Network

Registry information

Acronym: Gullstrand

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 2, 2010
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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