Digital Wavefront Sensing

Not Applicable

• Conditions: Wavefront Aberration, Corneal; Refractive Errors
• Interventions: Device: Holographic optical coherence tomography

• Registration Number: NCT04597255
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-15
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Study Start: 2020-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Holographic optical coherence tomography	Holographic optical coherence tomography	Healthy phakic participants

Primary Outcome Measures

Name	Time	Method
Qualitative description of lower order aberrations (LOA)	14 +/- 3 days	Zernike terms, RMS-error, Strehl ratio
Qualitative description of higher order aberrations (HOA)	14 +/- 3 days	Zernike terms, root mean square error; , Strehl ratio