Victus Versus Conventional

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991717
• Other study ID #: 13A06
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2013
• Last updated: January 20, 2014
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2014
• Source: Augenabteilung Allgemeines Krankenhaus Linz
• Contact: Matthias Bolz, MD
• Phone: +43 (0)732 7806
• Email: Matthias.Bolz[@]akh.linz.at
• Is FDA regulated: No
• Health authority: Austria: Ethic commitee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Victus
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
• Conventional Phaco
The capsulotomy as well as the lens fragmentation is performed manually.

Locations

Country	Name	City	State
Austria	AKh Linz	Linz	Oberösterreich

Sponsors (2)

Lead Sponsor	Collaborator
Matthias Bolz	Technolas Perfect Vision GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patients subjective perception	Patients' subjective perceptions of the two operative procedures	1 day	No
Other	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	No
Primary	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	No
Secondary	IOL overlap	The difference in the IOL overlap between group A and B. The IOL overlap, ?ROverlap, 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	No
Secondary	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	No