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Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

NCT02403206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2018-07-02

Study results available
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Summary

The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.

Conditions

  • Intumescent Cataract

Interventions

DEVICE

Femtosecond laser

Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens

PROCEDURE

Continuous Curvilinear Capsulorhexis (CCC)

Standard-of care manual procedure (using either needles or forceps) for creating capsulorhexis, ie., opening in capsular bag during anterior segment ophthalmic surgery

Sponsors & Collaborators

  • Alcon, a Novartis Company

    lead INDUSTRY

Principal Investigators

  • Clinical Manager, Surgical · Alcon, A Novartis Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-26
Primary Completion
2016-07-12
Completion
2016-08-24
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 NCT02403206 on ClinicalTrials.gov