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Study of the Efficiency and Workflow of Femtosecond Laser Assisted Cataract Surgery in a Spanish Public Hospital

NCT03931629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2019-04-30

No results posted yet for this study

Summary

Purpose: To assess the time-efficiency of a designated operation room (OR) workflow in the introduction of Femtosecond laser-assisted cataract surgery (FLACS, LenSx, Alcon®). The study was carried out in a public hospital with high volume of procedures.

Setting: Ophthalmology department of a tertiary referral Spanish public hospital.

Design: Prospective, controlled, surgical intervention study. Methods: A total of 167 eyes were enrolled, including 62 eyes undergoing conventional phacoemulsification surgery. In phase I, patients were assigned either to FLACS-I (n=63) or conventional phacoemulsification surgery (n=62). One surgeon operated the Femto-second laser, another finished the procedure, whereas another performed a conventional phacoemulsification. In the second phase (FLACS-II), all the surgeries were FLACS (n=42). A surgeon performed the FLACS procedure and two different surgeons completed the surgeries in separated ORs. Surgical and roll-over times of all the patients were recorded.

Conditions

  • Cataract
  • Cataract Mature
  • Cataract, Nuclear

Interventions

PROCEDURE

CONVENTIONAL PHACO

Cataract surgery by means of Femtosecond Laser-Assisted Cataract Surgery,

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2016-06-30
Completion
2016-06-30
FDA Device
Yes

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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 NCT03931629 on ClinicalTrials.gov