Victus Versus Conventional

An Open-label Investigator-masked Study Comparing Femtosecond Laser Assisted With Conventional Phacoemulsification Cataract Surgery

Cataract surgery is among the world's most frequently performed operations. It involves removal of an opaque lens from the human eye and implantation of an artificial lens. The operation is performed under local anaesthesia using ultrasound technology, by which the lens is emulsified and removed by suction.

Femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can improve the quality of cataract surgery and provide a new best possible standard of quality. In contrast to the conventional method the capsulotomy and the fragemntation are fully automatically performed with a femtosecond laser. In addition, the lens is fragmented by the laser, which substantially facilitates its removal and reduces the operation time.

Study to investigate whether the femtosecond laser cataract surgery causes any significant differences in clinical outcomes as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC).

Effective phako time (EPT) is defined as duration of phakoemulsifikation of the crystalline lens.

EPT of conventional surgery at intraoperative visit > EPT oflaser-assisted surgery at intraoperative visit

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Device: Victus; Device: Conventional Phaco

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4021
      • Recruiting
      • AKH Linz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years
• related cataract
• Ability to follow instructions from the treatment team
• Both eyes to receive surgery

Exclusion Criteria:

• Narrow pupils (in ther. mydriasis <6mm)
• Narrow orbits
• Sunken eyes
• manifest glaucoma treated with anti-glaucomatous therapy or prior surgery
• Conditions that pose a high risk of complications during surgery
• Known sensitivity to planned concomitant medications
• Patients with disorders of the ocular muscle, such as nystagmus or strabismus
• Patients who are blind on one eye
• Acute or chronic systemic and/or ocular illnesses that are clinically significant and will increase the risk to the subject or confound the outcomes of this study, such as but not restricted to diabetes mellitus, autoimmune/rheumatic or connective tissue diseases, dementia or epilepsy.
• Patients who are pregnant or nursing
• Patients who do not give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Victus Group; The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery	Device: Victus; The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Other: Conventional Group; The Conventional Group acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually	Device: Conventional Phaco; The capsulotomy as well as the lens fragmentation is performed manually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Phaco Time	EPT of the conventional cataract surgery (mesured intraoperativ = Visit 2) is smaller or equal to the EPT of the Laser-assisted cataract surgery (meausred intraoperativ = Visit 2)	surgery day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOL overlap	The difference in the IOL overlap between group A and B. The IOL overlap, ΔROverlap, is the euclidian distance between the center of mass of the capsulotomy and the center of mass of the IOL, representing the symmetry of the IOL-Capsulotomy aperture- overlap	1 month, 3 and 6 months
IOL Centration	The difference in the IOL centration between group A and B. The IOL centration is the euclidian distance between the center of mass of the IOL and the center of mass of the dilated pupil	1 month, 3 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients subjective perception	Patients' subjective perceptions of the two operative procedures	1 day
cornea, retina	Effects of the surgical techniques on the cornea and retina as assessed by optical coherence tomography, endothelial cell count or Pentacam.	1 month, 3 and 6 month

Collaborators and Investigators

• Sponsor: Matthias Bolz
• Collaborators: Technolas Perfect Vision GmbH
• Investigators: Principal Investigator: Matthias Bolz, MD, AKh Linz, Ophthalmology

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Victus; lensfragmentation; femtosecond laser assisted; capsulotomy,; manual, continuous curvilinear capsulorhexis (CCC); effective phaco time, phaco
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 13A06