Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing an Intraoperative vs. a Standard Wavefront Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749798
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

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

Condition or disease Intervention/treatment Phase
Cataract Procedure: Cataract surgery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. Wavefront aberration measurements [ Time Frame: 12 months ]
    Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749798


Contacts
Layout table for location contacts
Contact: Julius Hienert, MD 01 910 21-57564 office@viros.at
Contact: Nino Hirnschall, MD 01 910 21-57564 office@viros.at

Locations
Layout table for location information
Austria
Vienna Institute for Research in Ocular Surgery (VIROS) Recruiting
Vienna, Austria, 1140
Contact: Julius Hienert, MD    01 910 21-57564    office@viros.at   
Contact: Nino Hirnschall, MD    01 910 21-57564    office@viros.at   
Sponsors and Collaborators
Prim. Prof. Dr. Oliver Findl, MBA
Layout table for additonal information
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: November 21, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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, Vienna Institute for Research in Ocular Surgery:
Cataract
Wavefront measurement
Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases