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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04597255
Other study ID # OPHT-100419
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2020
Est. completion date December 2021

Study information

Verified date October 2020
Source Medical University of Vienna
Contact Doreen Schmidl, MD, PhD
Phone 40400
Email klin-pharmakologie@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Device:
Holographic optical coherence tomography
Descriptive wavefront analysis with holographic optical coherence tomography

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative description of lower order aberrations (LOA) Zernike terms, RMS-error, Strehl ratio 14 +/- 3 days
Primary Qualitative description of higher order aberrations (HOA) Zernike terms, root mean square error
, Strehl ratio
14 +/- 3 days
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