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

NCT03117426 | Completed DMC

• 1 other identifier: NL56878.068.16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions.

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

  3 months / 13 weeks

Secondary Outcomes (3)

• Binocular visual acuity

  3 months / 13 weeks

• Quality of Life

  pre-op and 3 months/13 weeks

• Contrast sensitivity

  3 months/13 weeks

Study Arms (2)

SYMFONY IOL

EXPERIMENTAL

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

AT LISA tri 839MP IOL

ACTIVE COMPARATOR

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

Interventions

SYMFONY IOL DEVICE

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

Also known as: EDOF IOL

SYMFONY IOL

AT LISA tri 839MP IOL DEVICE

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

Also known as: Trifocal IOL

AT LISA tri 839MP IOL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Abbott Medical Optics: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Rudy Nuijts, MD PhD

  University Eye Clinic Maastricht, Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 18, 2017
• Study Start: January 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: October 30, 2017
• Last Updated: May 2, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)