Digital Wavefront Sensing

Refractive Errors Clinical Trial

— DWS  

Official title:

Reproducibility and Comparison of Digital Wavefront Sensing With Conventional Shack-Hartmann Wavefront Sensing: an Explorative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04597255
• Other study ID #: OPHT-100419
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Corneal Wavefront Aberration
• Refractive Errors
• Wavefront Aberration, Corneal

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