Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

Study Overview
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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.

Official Title
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Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

Conditions
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Intumescent Cataract

Intervention / Treatment
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* Device: Femtosecond laser
* Procedure: Continuous Curvilinear Capsulorhexis (CCC)


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery | Device: Femtosecond laser<br>* Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens<br>* Other names: LenSx® Laser;|
| Active Comparator: Manual<br>Continuous curvilinear capsulorhexis performed during cataract surgery | Procedure: Continuous Curvilinear Capsulorhexis (CCC)<br>* Standard-of care manual procedure (using either needles or forceps) for creating capsulorhexis, ie., opening in capsular bag during anterior segment ophthalmic surgery<br>|

What is the study measuring?
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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) |