- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01663597
Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
Aberrations play a significant role in the visual process and can be divided in lower-order and higher-order aberrations. The former can be measured using the commercially available IOL Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity. Higher-order aberrations do not significantly influence visual acuity but affect the quality of vision and can cause halos, double vision, and night vision disturbances.
Background Cataract surgery has become a routine procedure in the developed countries. During this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However, these lenses do not account for individual optical biometry data or aberrations. Therefore, it is important to provide data for ametropic and emmetropic eyes as this information might improve future intraocular lens design and lead to individually adapted lenses for yielding optimal visual acuity and quality results.
The aim of the present study is to clarify the correlation between refractive errors/axial eye length and spherical aberrations of the cornea.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Vienna, Østrig, 1090
- Department of Clinical Pharmacology, Medical University of Vienna
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- men and women aged between 40 and 60 years
- normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- normal ophthalmic findings unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
- presence of any corneal or retinal disease
- Dry eye syndrome
- high astigmatism (>1 diopter)
- history of refractive surgery
- abuse of alcoholic beverages
- participation in a clinical trial in the 3 weeks preceding the study
- symptoms of a clinically relevant illness in the 3 weeks before the study day
- pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Cohort 1
40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters
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Cohort 2
40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter
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Cohort 3
40 subjects with emmetropia, -1 diopter to +1 diopter
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Cohort 4
40 subjects with hyperopia, +1.01 diopter and more
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Axial eye length
Tidsramme: 1 day
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1 day
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Refractive error
Tidsramme: 1 day
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1 day
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Corneal radius
Tidsramme: 1 day
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1 day
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Pupil diameter
Tidsramme: 1 day
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1 day
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Anterior chamber depth
Tidsramme: 1 day
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1 day
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Anterior corneal topography
Tidsramme: 1 day
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1 day
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Corneal thickness map
Tidsramme: 1 day
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1 day
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OPHTH-240512
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