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This clinical study is a prospective, post-market-clinical-follow-up study to investigate the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study follow-up extension to the Study #1304 titled as "A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Less or equal adverse events (e.g. retinal detachment, intraocular lens (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 primary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures. | 3 month |
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Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Stodulka, Dr. Med. | Gemini clinic, Zlin, Czech Republic 76001 | Principal Investigator |
| Kasu P Reddy, M.D. | MaxiVision Laser Centre Private Limited, Hyderabad, India | Principal Investigator |
| N Sreelakshmi, M.D. | MaxiVision Laser Centre Private Limited, Hyderabad, India | Principal Investigator |
| Steve Slade, M.D. | 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 | Device | "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 |