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Comparing an Intraoperative vs. a Standard Wavefront Device

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA (Other)
Overall Status
Unknown status
CT.gov ID
NCT03749798
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
15
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cataract surgery
 N/A

Detailed Description

Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy. While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a lenslet array to record distortions of light bundles coming from a single source form the retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast measures the aberration of a laser beam at different locations. All three systems compare distorsions of the measured light beams with a perfect optical system to calculate the wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects and different devices have been compared to each other. These results do not represent the typical cataract patient. Several factors, such as tear film instability and pupil size, have an influence on the measurements and these factors may change significantly with age.

Intraoperative measured data could help to get a better information about wavefront aberrations.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
To Collect and Compare Data With an Intraoperative Wavefront Device (HeLeNa) to a Standard Wavefront Device: an Explorative Pilot Study
Actual Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intraoperative wavefront measurement

Patients will be measured with an intraoperative wavefront device during cataract surgery

Procedure: Cataract surgery
Intraoperative wavefront measurements will be carried out during cataract surgery

Outcome Measures

Primary Outcome Measures

  1. Wavefront aberration measurements [12 months]

    Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 105 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Cataract

  • Age 21 and older

  • Able to understand the patient information

  • Willing to follow the instructions and attend all follow-up visits

  • Willing to sign informed consent prior to surgery

Exclusion Criteria:

  • Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars

  • Previous ocular surgeries on the study eye

  • Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)

  • Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery (VIROS) Vienna Austria 1140

Sponsors and Collaborators

  • Prim. Prof. Dr. Oliver Findl, MBA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT03749798
Other Study ID Numbers:
  • HeLeNa
First Posted:
Nov 21, 2018
Last Update Posted:
Nov 23, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
Cataract
Wavefront measurement
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Nov 23, 2018