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Study description
Title
Temporal
Dynamics of Higher Order Aberrations in the Human Eye: A
Comprehensive Study Across Morning and Evening
Examiner
Illes Tibor
Background of the study topic
This
study delves into the dynamic nature of higher order aberrations
(HOAs) in the human eye at different times of the day: morning and
evening. HOAs are optical imperfections that persist even after
correcting for spherical defocus and astigmatism, affecting
retinal image quality. With evidence suggesting that visual
experiences influence ocular growth, we aim to explore whether
variations in HOAs during different times of the day contribute to
the regulation of eye growth and refractive error development.
Understanding these temporal fluctuations in HOAs could provide
valuable insights for refining strategies to manage refractive
errors and optimizing visual performance.
Study description
Explore
the fluctuating optics of the human eye throughout the day in our
study. Investigating morning and evening variations, we aim to
uncover insights into how these optical imperfections impact eye
growth and refractive error development.
Study definitions
Study design
Analytical,
Longitudinal, Prospective, Experimental, Monocentric
Primary aim
Difference
in HOA
in the human eye vary throughout the day
Primary hypothesis
There
is no difference in HOA in the human eye vary throughout the day
Secondary aim(s)
Differences
in higher order aberrations (HOAs) concerning age
Secondary
hypotheses
There
is no differences
in higher order aberrations (HOAs) concerning age
Study organization
Materials / devices / software
–
Autorefractor
(Zeiss iProfiler)
-Phoropter
-Statistical
Software SPSS
-Wavefront
Aberrometer (Zeiss
iProfiler)
-Patient
Data Recording System
-Clinical
Examination Room
-Consent
Forms and Ethical Approval
Sample size
-Approx.
18 participants
Inclusion &
exclusion criteria
Inclusion
criteria:
Age
Range – Participants aged between 18 and 60 years.
Refractive
Error – Both individuals with high refractive error (e.g., myopia,
hyperopia, astigmatism) and those with normal or low refractive
error in range of spherical
refractive error max ±8dpt, cyl max -6dpt
Visual
Acuity – Individuals with a best-corrected visual acuity of 20/20
or better.
Good
General Health – Participants without significant systemic or
ocular health conditions that could affect study outcomes.
Exclusion
criteria
Previous
Eye Surgery – Individuals who have undergone refractive or
cataract surgery.
Ocular
Pathologies – Those with ocular pathologies such as glaucoma,
retinal disorders, or corneal abnormalities.
Pregnancy
– Exclusion of pregnant women due to potential hormonal influences
on the eyes.
Contact
Lens Wear – Individuals wearing contact lenses to be excluded due
to potential effects on wavefront measurements.
Systemic
Medications – Participants on medications known to influence
ocular parameters.
Inability
to Provide Informed Consent – Individuals unable to comprehend the
study requirements or provide informed consent.
Uncontrolled
Systemic Conditions – Exclusion of participants with uncontrolled
diabetes or hypertension.
Measurement
procedure
Participant
Preparation
Autorefraction
( Wavefront
Aberrometer)
VA
testing with phoropter
Data
Collection
Repeated
Measures (if applicable)
Data
Analysis
Quality
Control
Ethical
Considerations
Documentation
of all measurements after collecting and calculating data
Randomization
Participant
assignment to specific conditions will be randomized during the
measurement sessions
Control factors
Environmental
Conditions
Time
of Day
Head
Position and Alignment
Health
Status
Consistent
Measurement Techniques
Limitations
Fatigue
Accommodation
Previous
Visual Tasks e.g. Working on Computer
Analysis
Primary data
analysis
Size of pupil: 3 mm
Z (2,-2) Oblique Astigmatis
Z (2,0) Defocus
Z (2,2) WTR/ART Astigmatism
Z (3,-3) Oblique Trefoil
Z (3,-1) Vertical Coma
Z (3,1) Horizontal Coma
Z
(3,3) Horizontal Trefoil
Statistical
analysis
1.
Normal distribution?
Lilliefors
test
2.
Test for differences between M, J0 and J45 components
each
Bland-Altman
analysis
if
normal distribution: 1-way ANOVA
if
not: Kruskal-Wallis
3.
Test for differences in time duration
Excell
time calendar
Project management
Time schedule
Start:
02/2025
End:
11/2025
Preparation:
03/2025
Measurements:
03/2025
Analysis:
10/2025
Writing:
11/2025
QM / Supervision
Monthly
meeting with supervisor
Risk assessment
No
risk for study participant, as only CE certified devices are
Further project idea(s)
Difference
betwen Oculenz and digital Amblyz™ amblyopia device
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