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

NCT02023437 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2014-05-26

No results posted yet for this study

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".

Conditions

  • Cataract

Interventions

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.

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

Sponsors & Collaborators

  • Technolas Perfect Vision GmbH

    lead INDUSTRY

Principal Investigators

  • Pavel Stodulka, Dr. Med. · Gemini clinic, Zlin, Czech Republic 76001

  • Kasu P Reddy, M.D. · MaxiVision Laser Centre Private Limited, Hyderabad, India

  • N Sreelakshmi, M.D. · MaxiVision Laser Centre Private Limited, Hyderabad, India

  • Steve Slade, M.D. · Slade & Baker Vision Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Czechia
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023437 on ClinicalTrials.gov