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Low-add Multifocal vs. Monofocal IOLs

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ClinicalTrials.gov Identifier: NCT03749161
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:
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.

Condition or disease Intervention/treatment Phase
Cataract Device: Low-add multifocal IOL Device: Monofocal IOL Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Bilateral Low-add Multifocal Intraocular Lenses and Monofocal Intraocular Lenses: A Randomised Trial
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Lentis comfort
Patient will receive the low-add multifocal IOL during cataract surgery
Device: Low-add multifocal IOL
Lentis comfort, low-add multifocal, IOL

Experimental: Lentis L-313
Patient will receive the monofocal IOL Lentis L-313 during cataract surgery
Device: Monofocal IOL
Lentis L-313, monofocal IOL




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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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:

  • 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

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): NCT03749161


Contacts
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Contact: John Falasinnu, MD 01 / 91021 / 57559 office@viros.at
Contact: Nino Hirnschall, MD 01 / 91021 / 57562 office@viros.at

Locations
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Austria
Vienna Institute for Research in Ocular Surgery (VIROS) Recruiting
Vienna, Austria, 1140
Contact: John Falasinnu, MD    01 / 91021 / 57559    office@viros.at   
Contact: Nino Hirnschall, MD    01 / 91021 / 57562    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: NCT03749161     History of Changes
Other Study ID Numbers: Oculentis
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
Low-add intraocular lens

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases