Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

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.

Study Overview

• Status: Completed
• Conditions: Intumescent Cataract
• Intervention / Treatment: Device: Femtosecond laser; Procedure: Continuous Curvilinear Capsulorhexis (CCC)

• Study Type: Interventional
• Enrollment (Actual): 406
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• Other protocol-specified inclusion criteria may apply.

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.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser; Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery	Device: Femtosecond laser; Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens; Other Names: LenSx® Laser
Active Comparator: Manual; Continuous curvilinear capsulorhexis performed during cataract surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Capsular Tears (Anterior or Posterior) During Surgery	A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.	Day 0 (operative day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating Time in the Eye to Complete Entire Cataract Procedure	Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.	Day 0 (operative day)

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Clinical Manager, Surgical, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2015
• Primary Completion (Actual): July 12, 2016
• Study Completion (Actual): August 24, 2016

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTW860-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes