Low-add Multifocal vs. Monofocal IOLs
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Low-add multifocal IOL
Monofocal IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract Surgery, Low-add intraocular lens
Eligibility 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
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lentis comfort
Lentis L-313
Arm Description
Patient will receive the low-add multifocal IOL during cataract surgery
Patient will receive the monofocal IOL Lentis L-313 during cataract surgery
Outcomes
Primary Outcome Measures
Spectacle independence questionnaire
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
Best Corrected Distance Visual Acuity and Uncorrected Intermediate Visual Acuity
Best corrected distance and uncorrected intermediate visual acuity will be assessed using the ETDRS charts
Titmus Fly Stereo test
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.
Full Information
NCT ID
NCT03749161
First Posted
November 19, 2018
Last Updated
November 20, 2018
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03749161
Brief Title
Low-add Multifocal vs. Monofocal IOLs
Official Title
Comparison Between Bilateral Low-add Multifocal Intraocular Lenses and Monofocal Intraocular Lenses: A Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract Surgery, Low-add intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lentis comfort
Arm Type
Experimental
Arm Description
Patient will receive the low-add multifocal IOL during cataract surgery
Arm Title
Lentis L-313
Arm Type
Experimental
Arm Description
Patient will receive the monofocal IOL Lentis L-313 during cataract surgery
Intervention Type
Device
Intervention Name(s)
Low-add multifocal IOL
Intervention Description
Lentis comfort, low-add multifocal, IOL
Intervention Type
Device
Intervention Name(s)
Monofocal IOL
Intervention Description
Lentis L-313, monofocal IOL
Primary Outcome Measure Information:
Title
Spectacle independence questionnaire
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Best Corrected Distance Visual Acuity and Uncorrected Intermediate Visual Acuity
Description
Best corrected distance and uncorrected intermediate visual acuity will be assessed using the ETDRS charts
Time Frame
12 months
Title
Titmus Fly Stereo test
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Falasinnu, MD
Phone
01 / 91021 / 57559
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Hirnschall, MD
Phone
01 / 91021 / 57562
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Falasinnu, MD
Phone
01 / 91021 / 57559
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
Phone
01 / 91021 / 57562
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Low-add Multifocal vs. Monofocal IOLs
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