Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

Alcon

Status

Completed

Conditions

Intumescent Cataract

Treatments

Device: Femtosecond laser

Procedure: Continuous Curvilinear Capsulorhexis (CCC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02403206

CTW860-P001

Details and patient eligibility

About

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.

Enrollment

406 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.