NCT02023437

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".

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

December 6, 2013

Last Update Submit

May 22, 2014

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 month

Study Arms (2)

Experimental: Femtosecond laser cataract surgery

EXPERIMENTAL

"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.

Device: Femtosecond laser cataract surgery

Manual cataract surgery

ACTIVE COMPARATOR

"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

Interventions

Femtosecond laser cataract surgeryDEVICE

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.

Experimental: Femtosecond laser cataract surgery
Manual cataract surgeryDEVICE

"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation

Manual cataract surgery

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Gemini Eye Clinic

Zlín, 76001, Czechia

Location

MaxiVision Laser Centre Private Limited

Hyderabad, 500082, India

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Steve Slade, M.D.

    Slade & Baker Vision Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 30, 2013

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

CZ(1)IN(1)