Victus Versus Conventional

Matthias Bolz

Status: Unknown

Conditions: Cataract

Treatments: Device: Victus; Device: Conventional Phaco

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01991717

13A06

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Victus Group

Experimental group

Description:

The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery

Treatment:

Device: Victus

Conventional Group

Other group

Description:

The Conventional Group acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually

Treatment:

Device: Conventional Phaco