Clinical Trial: Evaluation of Stability After Implantation of Two Different Lens Models: FEMTIS-study

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

Official Title: A Randomised, Subject-masked Evaluation of Stability After Implantation of Two Different Lens Models: FEMTIS-study

Brief Summary: In this study the investigators will investigate the stability of lens position and the visual outcome after implantation of the new FEMTIS-IOL using FLACS capsulotomy compared to conventional placement of the IOL in the capsular bag. So far, there are no published studies using the FEMTIS-IOL. Therefore, the investigators will perform this randomized control trial.

Detailed Summary:

Cataract is a clouding of the crystalline lens which causes vision loss and blindness if untreated. Cataract surgery is the most frequently performed surgical intervention in medicine with an incidence of 880 surgeries per 100.000 population in 2010 amounting to a total number of over 160.000 surgeries per year in the Netherlands.1,3 The number of individuals with cataracts is predicted to reach 30 million by the year 2020.2 Due to aging of the general population this number of cataracts will only grow in the future.

For the last decade conventional phacoemulsification cataract surgery (CPCS) is the dominant form of cataract surgery in developed countries, accounting for over 90 percent of these procedures.4 The basic phacoemulsification procedure has remained largely unchanged over the past 20 years, including a series of steps: creating corneal incision, capsulorhexis and lensfragmentation.4 Although highly successful, each of the steps mentioned above are created manually which affects the safety and effectiveness of the procedure.

Since the first human eye was treated by femtosecond laser cataract surgery in 2008, the femtosecond-laser assisted cataract surgery (FLACS) became an innovative growing new technology in the world of cataract surgery.4-7 Femtosecond-lasers are capable of performing some of the most delicate and essential key steps during cataract surgery: capsulotomy, lens fragmentation, and corneal incisions. 'Automating' these steps and performing them with increased precision could lead to an improved quality of capsulotomy, easier lens fragmentation, and more precisely positioned corneal incisions, which in turn, lead to improved visual and refractive outcomes, a decrease in intra- and postoperative complication rates, and increased quality of life.

In or
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Decentration:To compare the amount of decentration between FEMTIS IOL versus a standard monofocal IOL (Acrysof monofocal IOL) using retro-illumination slitlamp photographs [ Time Frame: 13 weeks/3months ]

To compare the amount of decentration between FEMTIS IOL versus a standard monofocal IOL (Acrysof monofocal IOL) using retro-illumination slitlamp photographs


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rotation stability [ Time Frame: 13 weeks/3months ]
    To compare rotation stability between both IOls using retro-illumination slitlamp photographs
  • Tilt: To compare the amount of tilt between both IOls using Scheimpflug images [ Time Frame: 13 weeks/3months ]
    To compare the amount of tilt between both IOls using Scheimpflug images
  • Visual outcomes [ Time Frame: 13 weeks/3months ]
    Uncorrected (UDVA) and corrected (CDVA) distance visual acuity using ETDRS reading charts.


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: May 8, 2017
Date Started: January 1, 2017
Date Completion: October 30, 2017
Last Updated: May 12, 2017
Last Verified: May 2017