Clinical trial NCT04597255: Digital Wavefront Sensing
Official title: Reproducibility and Comparison of Digital Wavefront Sensing With Conventional Shack-Hartmann Wavefront Sensing: an Explorative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wavefront Aberration, Corneal
Refractive Errors
Keywords: digital wavefront sensing
optical coherence tomography
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A holographic optical coherence tomography (H-OCT) setup is used to detect the wavefront by means of phase reconstruction.

Detailed description: H-OCT will be tested in this study for its suitability for the qualitative investigation of aberrometry. We aim to achieve a digital equivalent for wavefront calculation of the widespread analog procedure commonly used with conventional wavefront-aberrometers. The results will be compared with those from a conventional analog wavefront calculation method.

In the course of this pilot study, 20 eyes of phakic and 10 eyes of pseudophakic subjects with suspected higher order aberrations will be examined using H-OCT.

Eligibility criteria: Inclusion Criteria:

1. Informed consent
2. Men and women aged between 18 and 85 years
3. Normal ophthalmic findings except refractive errors or suspected higher order aberrations
4. Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

1. Hyperopia \> +6 Dpt. and Myopia \< -6 Dpt.
2. Known ophthalmic diseases such as age related macular degeneration, diabetic retinopathy, glaucoma, retinal detachment or previous ocular trauma and surgeries except cataract extraction
3. Participation in a clinical trial in the previous 3 weeks
4. Presence of any abnormalities preventing reliable measurements as judged by the investigator
5. Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Qualitative description of lower order aberrations (LOA)
timeFrame: 14 +/- 3 days
measure: Qualitative description of higher order aberrations (HOA)
timeFrame: 14 +/- 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meidcal University of Vienna
name: Rainer Leitgeb, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar A, Drexler W, Leitgeb RA. Subaperture correlation based digital adaptive optics for full field optical coherence tomography. Opt Express. 2013 May 6;21(9):10850-66. doi: 10.1364/OE.21.010850.
citation: Liang J, Grimm B, Goelz S, Bille JF. Objective measurement of wave aberrations of the human eye with the use of a Hartmann-Shack wave-front sensor. J Opt Soc Am A Opt Image Sci Vis. 1994 Jul;11(7):1949-57. doi: 10.1364/josaa.11.001949.
citation: Kumar A, Wurster LM, Salas M, Ginner L, Drexler W, Leitgeb RA. In-vivo digital wavefront sensing using swept source OCT. Biomed Opt Express. 2017 Jun 21;8(7):3369-3382. doi: 10.1364/BOE.8.003369. eCollection 2017 Jul 1.