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

NCT ID: NCT02023437

Last Updated: 2014-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-03-31

Brief Summary

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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".

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Femtosecond laser cataract surgery

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

Group Type EXPERIMENTAL

Femtosecond laser cataract surgery

Intervention Type DEVICE

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.

Manual cataract surgery

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

Group Type ACTIVE_COMPARATOR

Manual cataract surgery

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technolas Perfect Vision GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pavel Stodulka, Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Gemini clinic, Zlin, Czech Republic 76001

Kasu P Reddy, M.D.

Role: PRINCIPAL_INVESTIGATOR

MaxiVision Laser Centre Private Limited, Hyderabad, India

N Sreelakshmi, M.D.

Role: PRINCIPAL_INVESTIGATOR

MaxiVision Laser Centre Private Limited, Hyderabad, India

Steve Slade, M.D.

Role: STUDY_CHAIR

Slade & Baker Vision Center

Locations

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Gemini Eye Clinic

Zlín, , Czechia

Site Status

MaxiVision Laser Centre Private Limited

Hyderabad, , India

Site Status

Countries

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Czechia India

Other Identifiers

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1304_3M

Identifier Type: -

Identifier Source: org_study_id

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