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

• ClinicalTrials.gov Identifier: NCT03117426
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: May 2, 2018
• Sponsor: Maastricht University Medical Center
• Collaborator: Abbott Medical Optics
• Information provided by (Responsible Party): Maastricht University Medical Center

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	Not Applicable

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.

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.

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 (Clinical Trial)
• 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: January 1, 2017
• Actual Primary Completion Date: September 30, 2017
• Actual Study Completion Date: October 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 Name: 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 Name: Trifocal IOL

Outcome Measures

Primary Outcome Measures :

1. Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions. [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Netherlands

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands, 6202 AZ

Sponsors and Collaborators

Maastricht University Medical Center

Abbott Medical Optics

Investigators

• Principal Investigator: Rudy Nuijts, MD PhD; University Eye Clinic Maastricht, Maastricht University Medical Centre

More Information

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT03117426
• Other Study ID Numbers: NL56878.068.16
• First Posted: April 18, 2017
• Last Update Posted: May 2, 2018
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No IPD will be shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maastricht University Medical Center:

Symfony Extended Range of Vision IOL; AT LISA tri 839MP IOL; Trifocal IOL; Extended depth of focus IOLs

Additional relevant MeSH terms:

Cataract; Presbyopia; Lens Diseases; Eye Diseases; Refractive Errors