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This clinical study is a randomized, controlled, open, prospective, multi-centre, multi-surgeon post-market-clinical-follow-up study to investigate the impact of cataract grade on the efficacy and safety of femtosecond laser assisted lens fragmentation to support phacoemulsification of the cataractous lens prior to intraocular lens (IOL) implantation.
The purpose of the multi-centre, multi-surgeon, randomized, controlled, prospective, post-market-clinical-follow-up study clinical study is to investigate the impact of cataract grade on the safety and efficacy of femtosecond laser assisted lens fragmentation for cataract surgery by using VICTUS femtosecond laser platform.
In this study patients with different cataract grades [judged by lens opacity classification system (LOCS) III on nuclear opalescence) will be randomly assigned to either a manual group or a laser group, and aspects on efficacy and safety will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femtosecond laser cataract surgery | Experimental | "Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure. |
|
| Manual cataract surgery | Active Comparator | "Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond laser cataract surgery | Device | The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens. The correct positioning of the cuts inside the lens can be verified by means of an optical coherence tomograph (OCT) before starting the laser assisted fragmentation process. Various surgical patterns will be used within this study. For each pattern different geometry/laser parameters can be adjusted individually according to each patient's cataract status. All the patients who are enrolled in the laser groups (all cataract grades) will be treated with femtosecond laser assisted capsulotomy before the femtosecond laser assisted lens fragmentation by VICTUS femtosecond laser platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Phacoemulsification Time | The effective phacoemulsification time (EPT) used the "Laser group" (pooled from all grades) during phacoemulsification is lower than or equal to that in the "Manual group" (pooled from all grades); p<0.05 will be considered statistically significant. | This criterion should be achieved at the day of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Less or equal adverse events (e.g. retinal detachment, IOL malposition, etc.) in "Laser group" (pooled from all cataract grades) compared with "Manual group" (pooled from all cataract grades); p<0.05 will be considered statistically significant. The secondary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures. | This purpose criterion should be achieved intraoperative, at 1 day, 1 week and 1 month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka, Dr. med | Gemini clinic, Zlin, Czech Republic 76001 | Principal Investigator |
| Kasu Prasad Reddy, MD | MaxiVision Laser Centre Private Limited, Hyderabad, India | Principal Investigator |
| N Sreelakshmi, MD | MaxiVision Laser Centre Private Limited, Hyderabad, India | Principal Investigator |
| Stephen Slade, MD | Slade & Baker Vision Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Zlín | 76001 | Czechia | |||
| MaxiVision Laser Centre Private Limited |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Manual cataract surgery | Procedure | "Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation |
|
| Hyderabad |
| 500082 |
| India |