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

May 22, 2014 updated by: Technolas Perfect Vision GmbH

A Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Zlin, Czech Republic, 76001
        • Gemini Eye Clinic
  • India
      • Hyderabad, India, 500082
        • MaxiVision Laser Centre Private Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technolas Perfect Vision GmbH

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1304_3M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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