NCT04597255

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 15, 2020

Last Update Submit

October 15, 2020

Conditions

Keywords

digital wavefront sensingoptical coherence tomography

Outcome Measures

Primary Outcomes (2)

  • Qualitative description of lower order aberrations (LOA)

    Zernike terms, RMS-error, Strehl ratio

    14 +/- 3 days

  • Qualitative description of higher order aberrations (HOA)

    Zernike terms, root mean square error , Strehl ratio

    14 +/- 3 days

Study Arms (1)

Holographic optical coherence tomography

EXPERIMENTAL

Healthy phakic participants

Device: Holographic optical coherence tomography

Interventions

Descriptive wavefront analysis with holographic optical coherence tomography

Also known as: Digital wavefront sensing, Digital aberrometry
Holographic optical coherence tomography

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 23669942BACKGROUND
  • 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.

    PMID: 8071736BACKGROUND
  • 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.

    PMID: 28717573BACKGROUND

MeSH Terms

Conditions

Corneal Wavefront AberrationRefractive Errors

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Rainer Leitgeb, Prof.

    Meidcal University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doreen Schmidl, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doreen Schmidl [dschmidl]

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 22, 2020

Record last verified: 2020-10