Back to resultsLong-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Femtosecond laser cataract surgery
Manual cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.
Sites / Locations
- Gemini Eye Clinic
- MaxiVision Laser Centre Private Limited
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental: Femtosecond laser cataract surgery
Manual cataract surgery
Arm Description
"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.
"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02023437
First Posted
December 6, 2013
Last Updated
May 22, 2014
Sponsor
Technolas Perfect Vision GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02023437
Brief Title
Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technolas Perfect Vision GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Femtosecond laser cataract surgery
Arm Type
Experimental
Arm Description
"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.
Arm Title
Manual cataract surgery
Arm Type
Active Comparator
Arm Description
"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation
Intervention Type
Device
Intervention Name(s)
Femtosecond laser cataract surgery
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Manual cataract surgery
Intervention Description
"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation
Primary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Stodulka, Dr. Med.
Organizational Affiliation
Gemini clinic, Zlin, Czech Republic 76001
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kasu P Reddy, M.D.
Organizational Affiliation
MaxiVision Laser Centre Private Limited, Hyderabad, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
N Sreelakshmi, M.D.
Organizational Affiliation
MaxiVision Laser Centre Private Limited, Hyderabad, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Slade, M.D.
Organizational Affiliation
Slade & Baker Vision Center
Official's Role
Study Chair
Facility Information:
Facility Name
Gemini Eye Clinic
City
Zlin
ZIP/Postal Code
76001
Country
Czech Republic
Facility Name
MaxiVision Laser Centre Private Limited
City
Hyderabad
ZIP/Postal Code
500082
Country
India
12. IPD Sharing Statement
Learn more about this trial
Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery
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