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OpenTrials
Completed

NCT Number: NCT02403206

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.

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Key information

Conditions

Intumescent Cataract

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femtosecond laser

Device

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

Other names: LenSx® 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

Primary outcomes

  1. Percentage of Capsular Tears (Anterior or Posterior) During Surgery

    Time frame: Day 0 (operative day)

    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.

Secondary outcomes

  1. Operating Time in the Eye to Complete Entire Cataract Procedure

    Time frame: Day 0 (operative day)

    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.

Sponsors and collaborators

Lead sponsor

Alcon, a Novartis Company

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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