Digital Wavefront Sensing

NCT ID: NCT04597255

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Wavefront Aberration, Corneal Refractive Errors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Holographic optical coherence tomography

Healthy phakic participants

Group Type EXPERIMENTAL

Holographic optical coherence tomography

Intervention Type DEVICE

Descriptive wavefront analysis with holographic optical coherence tomography

Interventions

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Holographic optical coherence tomography

Descriptive wavefront analysis with holographic optical coherence tomography

Intervention Type DEVICE

Other Intervention Names

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Digital wavefront sensing Digital aberrometry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Doreen Schmidl

Doreen Schmidl [dschmidl]

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rainer Leitgeb, Prof.

Role: PRINCIPAL_INVESTIGATOR

Meidcal University of Vienna

Central Contacts

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Doreen Schmidl, MD, PhD

Role: CONTACT

40400 ext. 1988

References

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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.

Reference Type BACKGROUND
PMID: 23669942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8071736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28717573 (View on PubMed)

Other Identifiers

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OPHT-100419

Identifier Type: -

Identifier Source: org_study_id

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