Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

NCT02403206 | Completed Results FDA Device

• 1 other identifier: CTW860-P001
• Study Type: interventional
• Target: 406
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Operating Time in the Eye to Complete Entire Cataract Procedure

  Day 0 (operative day)

Study Arms (2)

Laser

EXPERIMENTAL

Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery

Device: Femtosecond laser

Manual

ACTIVE COMPARATOR

Continuous curvilinear capsulorhexis performed during cataract surgery

Procedure: Continuous Curvilinear Capsulorhexis (CCC)

Interventions

Femtosecond laser DEVICE

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

Also known as: LenSx® Laser

Laser

Continuous Curvilinear Capsulorhexis (CCC) PROCEDURE

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

Manual

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

MeSH Terms

Interventions

Capsulorhexis

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Global Brand Medical Affairs Lead, CDMA Surgical
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Surgical

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: March 26, 2015
• Primary Completion: July 12, 2016
• Study Completion: August 24, 2016
• Last Updated: July 2, 2018
• Results First Posted: July 25, 2017

Record last verified: 2017-06