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Low-add Multifocal vs. Monofocal IOLs

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. Identifier: NCT03749161
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Tracking Information
First Submitted Date  ICMJE November 19, 2018
First Posted Date  ICMJE November 21, 2018
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
Spectacle independence questionnaire [ Time Frame: 12 months ]
Spectacle independence will be assessed using a questionnaire. In this questionnaire the patient will be asked about usage of spectacles for far, near and intermediate distance. Best result will be if the patient is independent from any spectacles in the different distances.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Best Corrected Distance Visual Acuity and Uncorrected Intermediate Visual Acuity [ Time Frame: 12 months ]
    Best corrected distance and uncorrected intermediate visual acuity will be assessed using the ETDRS charts
  • Titmus Fly Stereo test [ Time Frame: 12 months ]
    Stereo Vision assessment will be done using the Titmus Fly Stereo test. The patients will be asked to detect stereoscopic objects of different difficulty levels. The result will be better, the more correct stereoscopic objects the patient will detect.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Low-add Multifocal vs. Monofocal IOLs
Official Title  ICMJE Comparison Between Bilateral Low-add Multifocal Intraocular Lenses and Monofocal Intraocular Lenses: A Randomised Trial
Brief Summary Compare low-add multifocal IOLs with monofocal IOLs to evaluate if patients in the low-add multifocal IOL group have better unaided distance visual acuity compared to the monofocal group.
Detailed Description

Spectacle independence is one of the main aims in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satisfaction in distance vision, spectacle dependence for intermediate vision, reading and other near vision tasks is the usual result.

There are different techniques to reduce spectacle dependence, the most common one is the use of multifocal IOLs. However, a variable number of patients complain of problems, such as glare or haloes (positive dysphotopsia symptoms). Dysphotopsia symptoms may vary significantly from patient to patient. The real incidence of dysphotopsia like symptoms after cataract surgery and multifocal IOL is unknown and the implantation of multifocal IOLs is a commonly accepted contraindication in patients who are night drivers. Another characteristic of many multifocal IOLs is that it can provide patients with excellent near and distance vision but lack in the intermediate range.

One option to enhance intermediate vision and to leave patients with good contrast sensitivity is the use of low-add multifocal IOLs. These IOLs are adequate to expectations a lot of patients have, who were used to have a good distance vision and who were wearing spectacles when performing near vision tasks before surgery. Many of these patients would prefer to keep their reading spectacles after surgery and ideally would like to function well at distance and intermediate (60 to 80 cm - computer distance, household work…) range without glasses.

One example of these low-add multifocal IOLs is the LENTIS Comfort MF15 with a near add of 1.50D (on IOL plane). Its single, blended transition zone works to deliver patients the same kind of distance vision as a monofocal IOL with the addition of enhanced intermediate vision. In particular, this design provides improved vision at a distance of 60 cm and more. Additional key features of the Comfort IOL include good contrast sensitivity for twilight vision, optimized depth of focus, and natural imaging quality and color sensitivity. Especially this type of IOL may lead to more tolerance of postoperative refractive errors due to biometry and IOL power calculation imprecision. This should result in better unaided distance vision and therefore higher patient satisfaction after cataract surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Device: Low-add multifocal IOL
    Lentis comfort, low-add multifocal, IOL
  • Device: Monofocal IOL
    Lentis L-313, monofocal IOL
Study Arms  ICMJE
  • Experimental: Lentis comfort
    Patient will receive the low-add multifocal IOL during cataract surgery
    Intervention: Device: Low-add multifocal IOL
  • Experimental: Lentis L-313
    Patient will receive the monofocal IOL Lentis L-313 during cataract surgery
    Intervention: Device: Monofocal IOL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age-related cataract in both eyes
  • Scheduled for bilateral cataract surgery
  • Motivated to be less spectacle dependant in the distance to intermediate vision range
  • Patients with an expected BCDVA of 0.8 snellen score or better after surgery
  • Patients with the need of an IOL Power in the range of 10 to 30D (biometry performed with the IOL master 700)
  • Age 21 and older
  • Written informed consent prior to recruitment

Exclusion Criteria:

  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
  • Retinopathia pigmentosa
  • Chronic uveitis
  • Amblyopia
  • Pupil decentration > 1mm center shift
  • preceded retinal surgery
  • preceded Laser-in-situ-Keratomileusis (LASIK)
  • Any ophthalmic abnormality that could compromise visual function or the measurements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 105 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Falasinnu, MD 01 / 91021 / 57559
Contact: Nino Hirnschall, MD 01 / 91021 / 57562
Listed Location Countries  ICMJE Austria
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03749161
Other Study ID Numbers  ICMJE Oculentis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
Study Sponsor  ICMJE Prim. Prof. Dr. Oliver Findl, MBA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vienna Institute for Research in Ocular Surgery
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP