The Femtosecond Laser in Residency Training (FLIRT) Pilot Study
NCT03115216 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-09-24
Summary
This pilot study aims to primarily assess the rate of complication of anterior vitrectomy for patients undergoing femtosecond laser-assisted (FLA) cataract extraction and intraocular lens placement (CEIOL) compared to manual CEIOL, when performed by resident physicians under direct attending supervision. In this pilot study, the investigators aim to assess what the incidence of anterior vitrectomy is for each group, in order to better understand the sample size needed to assess whether there is a difference between these two groups. Secondarily, it will gather preliminary data on safety and refractive outcomes for patients undergoing these interventions.
Conditions
- Cataract
- Intraocular Lens Implantation
Interventions
- PROCEDURE
-
FLA-CEIOL
Femtosecond laser-assisted cataract extraction and intraocular lens placement
- PROCEDURE
-
CEIOL
Manual cataract extraction and intraocular lens placement
Sponsors & Collaborators
-
Alcon Research
collaborator INDUSTRY -
University of Southern California
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-31
- Primary Completion
- 2018-07-31
- Completion
- 2018-07-31
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