Diurnal Changes of the Cornea - a Pilot Study

NCT ID: NCT02155556

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-08-31

Brief Summary

Aim of this study is to gain a better understanding of the diurnal changes of the cornea to improve toric IOL power calculations.

Detailed Description

Higher patient expectations concerning unaided visual acuity after cataract surgery has led to an increase in use of toric intraocular lenses (toric IOLs) for the correction of corneal astigmatism. Although it was shown that toric IOLs significantly reduce astigmatism, there is still some difficulty in predicting the remaining astigmatism correctly. The main source of error appears to be the pre-operative measurement of the cornea. However, it is questionable, if this error derives from a measurement error due to the imprecise measurement technique, or natural diurnal changes of the cornea. Additionally, measurements of the cornea pose several challenges: different corneal biometry devices cannot be used interchangeably and it is difficult to decide, which device is measuring the cornea correctly as there is no gold standard.

Especially, in eyes with small corneal astigmatism the error increases. Recently it was shown that the astigmatism meridian was on median 9° off for corneas with 1.0D of astigmatism and only 4° for corneas with 2.0D of astigmatism. Similar findings were observed by Shammas et al. Norrby furthermore showed that 5% of all corneas show more than 0.5D of fluctuations between measurements at different (post-operative) time-points. The reasons are not explored, but diurnal changes, temperature and humidity potentially influencing the tear film, as well as pupil size and asphericity of the cornea could play a role. Read and Collins observed diurnal changes of corneal radii within 24 hours, but in their study only young healthy volunteers were included and only one measurement device (Scheimpflug imaging, Pentacam HR) was used. Lau and Pye and Shen et al. measured the diurnal changes of the cornea, but no data concerning corneal radii were reported. Harper et al. observed diurnal changes of the central corneal thickness. However, none of these studies investigated on diurnal changes of the corneal radii in the elderly population. Aim of this study is to gain a better understanding of the diurnal changes of the cornea to improve toric IOL power calculations.

Conditions

Astigmatism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 21 years, or above
• Signed informed consent

Exclusion Criteria

• Ophthalmic diseases such as significant macular degeneration, glaucoma, diabetic retinopathy, etc.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

MD, MBA

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oliver Findl, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

Locations

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, , Austria

Countries

Austria

Other Identifiers

DIU

Identifier Type: -

Identifier Source: org_study_id