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Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery

NCT01982006 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 920

Last updated 2018-10-04

No results posted yet for this study

Summary

Cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in France. A new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the French healthcare insurance.

Conditions

  • Cataract

Interventions

PROCEDURE

Cataract surgery with Phacoemulsification

Each patients randomized in the phaco arm will undergo a conventional cataract surgery. Corneal incisions will be manually performed using the same calibrated blade and at the same location for all procedures of one surgeon. Phacoemulsification machine used to perform cataract surgery in each center will be the same for all patients included in the center. The IOL (IntraOcular Lens) used in each center will be the same for all patients treated in the center.

DEVICE

Femtosecond laser-assisted cataract surgery

Each patients randomized in the femto arm will undergo a femtosecond laser assisted cataract surgery. Corneal incisions will be performed by the laser. Number, size and location of the incisions must be the same than in the phaco arm for all patients treated by one surgeon. Phacoemulsification machine used to remove the liquefied lens will be the same than in the phaco arm The IOL used in each center will be the same than in the phaco arm

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Cédric SCHWEITZER, MD · University Hospital Bordeaux, France

  • BENARD Antoine, MD · University Hospital Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-09
Primary Completion
2016-12-15
Completion
2016-12-15

Countries

  • France

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 NCT01982006 on ClinicalTrials.gov