Diurnal Changes of the Cornea - a Pilot Study

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA (Other)
Overall Status
Completed
CT.gov ID
NCT02155556
Collaborator
(none)
20
1
2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Diurnal Changes of the Cornea - a Pilot Study
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Aug 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    1. Descriptive analysis of diurnal changes of the corneal radii (in diopters) and orientation of the steep meridian (in degrees) in young healthy subjects and elderly patients [24 hours]

    Secondary Outcome Measures

    1. Comparison of the corneal radii (in diopters) and orientation of the steep meridian (in degrees) between different measuring devices [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 21 years, or above

    • Signed informed consent

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna Austria 1140

    Sponsors and Collaborators

    • Prim. Prof. Dr. Oliver Findl, MBA

    Investigators

    • Principal Investigator: Oliver Findl, MD, MBA, VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prim. Prof. Dr. Oliver Findl, MBA, MD, MBA, Vienna Institute for Research in Ocular Surgery
    ClinicalTrials.gov Identifier:
    NCT02155556
    Other Study ID Numbers:
    • DIU
    First Posted:
    Jun 4, 2014
    Last Update Posted:
    Mar 16, 2020
    Last Verified:
    Mar 1, 2020
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2020