Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision

NCT ID: NCT02155348

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-05-31

Brief Summary

More and more patients like to achieve complete spectacle independence after cataract surgery. Two possibilities that are particularly often used today are on the one hand multifocal lenses, and on the other hand the concept of monovision (in doing so one eye is adjusted for closeness and the other focuses for distance). The drawback with multifocal lenses is that some patients are bothered by glare phenomena, the disadvantage of monovision is that some patients lose a little of their stereo vision.

The aim of this study is a direct comparison of these two methods. Therefore 70 patients are included in 2 groups. In one group, patients receive on both sides a multifocal IOL with a near addition of +1.5 D and the patients in the second group receive monovision. One hour, 1 week and 3 months after surgery, patients are invited and tests for visual accuity are performed for near vision (40cm), intermediate vision (80cm) and distant vision (400cm). Furthermore, contrast sensitivity and stereopsis of patients is assesed. Additional measurements for detecting the tilt of the lens will be performed.

Detailed Description

Spectacle independence is a central aim 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 reading and other near vision tasks is the usual result.

The current technique available to surgeons to reduce spectacle dependence is to use bilateral multifocal IOLs. However, a variable number of patients do complain of problems with glare, haloes and lights especially in the hours of darkness (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 6 and the implantation of multifocal IOLs is a commonly accepted contraindication in patients who are night drivers.

Another option to allow spectacle independence is monovision. Monovision is where one eye can see clearly in the distance and the other eye is intentionally made short-sighted so that it has either near reading vision (full monovision) or intermediate (arms length) or distance vision (limited monovision). Monovision has two major advantages, very little dysphotopsia and it is cheaper compared to multifocal IOLs. However, disadvantages are a reduced stereopsis and there is a need for neuroadaptation.

The rationale of this trial was to compare bilateral multifocal intraocular lenses (MIOLs) with monovision after cataract surgery concerning visual function and spectacle independence.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multifocal group

Bilateral cataract surgery with implantation of multifocal IOLs

Group Type: ACTIVE_COMPARATOR

Bilateral cataract surgery with implantation of multifocal IOLs

Intervention Type: PROCEDURE

Lentis LS-313, multifocal, target refraction of the distance-dominant eye: 0.00D, target refraction of the other eye: -0.50D

Lentis LS-313

Intervention Type: DEVICE

Monovision

Bilateral cataract surgery with monovision

Group Type: ACTIVE_COMPARATOR

Bilateral cataract surgery with monovision

Intervention Type: PROCEDURE

Lentis L-313, monofocal, target refraction of the distance-dominant eye: 0.00D to -0.25D, target refraction of the other eye: -1.50D

Lentis LS-313

Intervention Type: DEVICE

Interventions

Bilateral cataract surgery with implantation of multifocal IOLs

Lentis LS-313, multifocal, target refraction of the distance-dominant eye: 0.00D, target refraction of the other eye: -0.50D

Intervention Type: PROCEDURE

Bilateral cataract surgery with monovision

Lentis L-313, monofocal, target refraction of the distance-dominant eye: 0.00D to -0.25D, target refraction of the other eye: -1.50D

Intervention Type: PROCEDURE

Lentis LS-313

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age-related cataract
• Scheduled for bilateral cataract extraction
• Motivated to be less spectacle dependant
• Age 21 and older
• Corneal astigmatism ≤ 1.5 D (Keratometry, IOL Master 500)
• written informed consent prior to recruitment

Exclusion Criteria

• Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
• Retinitis 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Prim. Prof. Dr. Oliver Findl, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Oliver Findl, MD, MBA

Role: primary

oliver@findl.at

+43 1 91021 ext. 84611

Other Identifiers

Lentis

Identifier Type: -

Identifier Source: org_study_id