A Randomised Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLs

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03117426

Collaborator

Abbott Medical Optics (Industry)

Enrollment

Location

Arms

9.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.

The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena, Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of postoperative achieved visual acuity at different distances, patient satisfaction (e.g. spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare) under different light conditions. So far, there are no published studies comparing both IOLs. Therefore, we will perform this randomized control trial.

Condition or Disease	Intervention/Treatment	Phase
Cataract Presbyopia	Device: SYMFONY IOL Device: AT LISA tri 839MP IOL	N/A

Detailed Description

Rationale: Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.

Objective: The primary objective of this study is to compare the postoperative visual outcomes in a series of patients bilaterally implanted with the AT LISA IOL versus those bilaterally implanted with the Symfony IOL.

Study design: Single-centre randomised clinical trial. Study population: 30 patients (60 eyes) with bilateral cataract who require cataract surgery.

Intervention (if applicable): Cataract surgery with bilateral implantation of either a Symfony IOL or an AT LISA IOL.

Main study parameters/endpoints: The primary endpoint is the binocular uncorrected visual acuity at 66 cm distance under both photopic and mesopic conditions 13 weeks postoperatively. Secondary endpoints are: binocular (un)corrected visual acuity at far (4 meters) and near (40 cm) under both photopic and mesopic conditions, reading performance, patient satisfaction, and complication profile.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both lens models used in this study are CE-marked and commercially available. The pre- and postoperatively examinations to be performed in this study are part of the regular medical treatment of patients with cataract who need cataract surgery. There is one more postoperative visit compared to standard cataract surgery. Potential risks, such as postoperative residual refractive error, halo's and glare, associated with multifocal IOL implantation are expected to be comparable or even lower after implantation of Symfony IOL. Spectacle-independency and high quality visual acuity postoperatively are the expected major benefits of implantation of the Symfony IOL.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomised, Subject-masked Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLs: the Symfony-study

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Oct 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYMFONY IOL The unique design of this IOL merges two complementary enabling technologies: (1) its diffractive echelette design feature extends the range of vision, and (2) achromatic technology corrects chromatic aberration for enhanced contrast sensitivity. Theoretically, combining these two mechanism of action results in a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs (see figure 2). Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag.	Device: SYMFONY IOL IOL for presbyopic treatment in patients undergoing cataract surgery. EDOF IOL. Other Names: EDOF IOL
Active Comparator: AT LISA tri 839MP IOL This trifocal IOL provides three useful focal distances, far, intermediate, and near, and therefore aims to provide functional visual restoration after cataract surgery. Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag.	Device: AT LISA tri 839MP IOL IOL for presbyopic treatment in patients undergoing cataract surgery. Trifocal IOL Other Names: Trifocal IOL

Arm

Intervention/Treatment

Experimental: SYMFONY IOL

The unique design of this IOL merges two complementary enabling technologies: (1) its diffractive echelette design feature extends the range of vision, and (2) achromatic technology corrects chromatic aberration for enhanced contrast sensitivity. Theoretically, combining these two mechanism of action results in a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs (see figure 2). Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag.

Device: SYMFONY IOL

IOL for presbyopic treatment in patients undergoing cataract surgery. EDOF IOL.

Other Names:

EDOF IOL

Active Comparator: AT LISA tri 839MP IOL

This trifocal IOL provides three useful focal distances, far, intermediate, and near, and therefore aims to provide functional visual restoration after cataract surgery. Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag.

Device: AT LISA tri 839MP IOL

IOL for presbyopic treatment in patients undergoing cataract surgery. Trifocal IOL

Other Names:

Trifocal IOL

Outcome Measures

Primary Outcome Measures

Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions. [3 months / 13 weeks]
The mean binocular uncorrected intermediate visual acuity at 66 cm under both photopic and mesopic conditions at 13 weeks (3 months) postoperatively

Secondary Outcome Measures

Binocular visual acuity [3 months / 13 weeks]
At 4 meter, 40 cm, including reading speed
Quality of Life [pre-op and 3 months/13 weeks]
QoL questionnaires
Contrast sensitivity [3 months/13 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Minimum 21 years of age
Bilateral cataract
Bilateral implantation of Tecnis Symfony IOL or AT LISA IOL (same lens model in both eyes)
Expected postoperative astigmatism ≤ 1.00 D (combination with FLACS AK is tolerated up to 1.5 D preoperative astigmatism)
IOL power calculation between +10.00 D and 32.00 D
Expected postoperative best-corrected visual acuity of logMAR +0.3 or better
Availability to undergo second eye surgery within 2 weeks of the first eye surgery
Willing and able to comply with scheduled visits and other study procedures
Signed informed consent.

Exclusion Criteria:

Previous corneal surgery and/or reshaping
Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
Irregular astigmatism
Keratoconus
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
Extensive age related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen)
Extensive visual field loss (e.g., glaucoma, history of cerebral vascular accidents, etc.)
Extensive diabetic macular disease
History of amblyopia and/or strabismus
Pseudoexfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
Cognitive, cerebral or concentration disorders (e.g. dementia, Parkinson, history of CVA, etc.)
Suturing of incision required at time of surgery
Complications during surgery of the first eye.