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High Resolution Immersion Ultrasound for iIOL Power Calculation

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: NCT03749486
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Brief Summary:
Assess is the additional use of high resolution immersion ultrasound measurements improve the refractive outcome after cataract surgery.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: To Assess if Using a High Resolution Immersion Ultrasound Measurement Improves Intraocular Lens Power Calculation
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Ultrasound

Arm Intervention/treatment
Experimental: ArcScan
High resolution immersion ultrasound measurement before Cataract surgery
Procedure: Cataract surgery
Cataract surgery will be done following ArcScan measurement




Primary Outcome Measures :
  1. Difference in mean absolute error in refractive outcome [ Time Frame: 12 months ]
    The difference in refractive error will be measured using auto- and subjective refraction


Secondary Outcome Measures :
  1. Anterior chamber depth and lens thickness measurement [ Time Frame: 12 months ]
    Anterior chamber depth and lens thickness will be measured using the IOL Master 700

  2. IOL tilt and decentration [ Time Frame: 12 months ]
    IOL tilt and decentration will be assessed using the Purkinjemeter



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.


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Ages Eligible for Study:   21 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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): NCT03749486


Contacts
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Contact: Sahand Amir-Asgari, MD 01 910 21-57557 office@viros.at
Contact: Julius Hienert, MD 01 910 21-57564 office@viros.at

Locations
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Austria
Vienna Institute for Research in Ocular Surgery (VIROS) Recruiting
Vienna, Austria, 1140
Contact: Sahand Amir-Asgari, MD    01 910 21-57557    office@viros.at   
Contact: Julius Hienert, MD    01 910 21-57564    office@viros.at   
Sponsors and Collaborators
Prim. Prof. Dr. Oliver Findl, MBA
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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT03749486    
Other Study ID Numbers: ArcScan
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 surgery
High resolution immersion ultrasound
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases