Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-26

Study Completion Date

2016-08-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Intumescent 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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Laser

Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery

Group Type EXPERIMENTAL

Femtosecond laser

Intervention Type DEVICE

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

Manual

Continuous curvilinear capsulorhexis performed during cataract surgery

Group Type ACTIVE_COMPARATOR

Continuous Curvilinear Capsulorhexis (CCC)

Intervention Type PROCEDURE

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

Interventions

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Femtosecond laser

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

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Other Intervention Names

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LenSx® Laser

Eligibility Criteria

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Inclusion Criteria

* Willing to undergo cataract surgery.
* Able to lie flat in a supine position.
* Able to understand and willing to sign the Informed Consent Form (ICF).
* Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.

Exclusion Criteria

* Pregnant or lactating mothers.
* Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
* Corneal opacity that would interfere with the laser beam.
* Presence of blood or other material in the anterior chamber.
* Hypotony or presence of corneal implant.
* Poorly dilating pupils.
* Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
* Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
* Any contraindication to cataract surgery.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No