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Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

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ClinicalTrials.gov Identifier: NCT02023437
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH

Brief Summary:
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".

Condition or disease Intervention/treatment Phase
Cataract Device: Femtosecond laser cataract surgery Device: Manual cataract surgery Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery
Study Start Date : December 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Experimental: Femtosecond laser cataract surgery
"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.
Device: Femtosecond laser cataract surgery
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.

Active Comparator: Manual cataract surgery
"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation
Device: Manual cataract surgery
"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 month ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023437


Locations
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Czech Republic
Gemini Eye Clinic
Zlin, Czech Republic, 76001
India
MaxiVision Laser Centre Private Limited
Hyderabad, India, 500082
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
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Principal Investigator: 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
Study Chair: Steve Slade, M.D. Slade & Baker Vision Center

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Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT02023437     History of Changes
Other Study ID Numbers: 1304_3M
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases