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

Sponsor

Technolas Perfect Vision GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT02023437

Collaborator

(none)

132

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

22.3

Patients Per Site Per Month

Study Details

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".

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Femtosecond laser cataract surgery Device: Manual cataract surgery	Phase 4

Study Design

Study Type:

Interventional

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 :

Dec 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adverse Events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gemini Eye Clinic	Zlin		Czech Republic	76001
2	MaxiVision Laser Centre Private Limited	Hyderabad		India	500082

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Technolas Perfect Vision GmbH

ClinicalTrials.gov Identifier:

NCT02023437

Other Study ID Numbers:

1304_3M

First Posted:

Dec 30, 2013

Last Update Posted:

May 26, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of May 26, 2014