Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

Refractive Errors Clinical Trial

Official title:

Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663597
• Other study ID #: OPHTH-240512
• Status: Completed
• Phase: N/A
• First received: August 9, 2012
• Last updated: August 28, 2013
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Axial Length, Eye
• Corneal Wavefront Aberration
• Refractive Errors

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial eye length		1 day	No
Secondary	Refractive error		1 day	No
Secondary	Corneal radius		1 day	No
Secondary	Pupil diameter		1 day	No
Secondary	Anterior chamber depth		1 day	No
Secondary	Anterior corneal topography		1 day	No
Secondary	Corneal thickness map		1 day	No