Project Gullstrand - European Project for the Determination NCT01173614

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01173614
Other study ID #	ECR-CCRS-2010-01
Secondary ID
Status	Completed
Phase	N/A
First received	July 28, 2010
Last updated	June 14, 2016
Start date	January 2011
Est. completion date	June 2016

Study information
Verified date	June 2016
Source	European Vision Institute Clinical Research Network
Contact	n/a
Is FDA regulated	No
Health authority	European Union: European Medicines AgencyPortugal: Ethics Committee for Clinical Research
Study type	Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status	Completed
Enrollment	1646
Est. completion date	June 2016
Est. primary completion date	June 2015
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	N/A and older
Eligibility	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

Time Perspective: Prospective

Related Conditions & MeSH terms

Normal Subjects, Ametropia

Locations
Country	Name	City	State
Spain	VISSUM - Instituto Oftalmológico de Alicante	Alicante

Sponsors *(1)*
Lead Sponsor	Collaborator
European Vision Institute Clinical Research Network

Country where clinical trial is conducted

Spain,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No