Victus Versus Conventional

Study Overview
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Brief Summary
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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

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Victus
* Device: Conventional Phaco


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Victus, lensfragmentation, femtosecond laser assisted, capsulotomy,, manual, continuous curvilinear capsulorhexis (CCC), effective phaco time, phaco