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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:

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 implant
Sponsor: Maastricht University Medical Center

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: April 12, 2017
Date Started: January 1, 2017
Date Completion: October 30, 2017
Last Updated: April 20, 2017
Last Verified: April 2017