Zero CDE Technique for Lens Removal During FLACS

February 5, 2026 updated by: Raymond Stein, Bochner Eye Institute

Zero CDE Technique for Lens Nucleus Removal During Femtosecond Laser-Assisted Cataract Surgery

The Zero CDE (cumulative dissipated energy) technique facilitates cataract removal with no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye. In the investigator's experience, this technique consistently shows a stable anterior chamber, a low complication rate, and a rapid return of vision following cataract surgery. This prospective study aims to document the outcomes with the zero CDE technique during femtosecond laser-assisted cataract surgery (FLACS).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5R1A9
        • Bochner Eye Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients over the age of 50 years with operable cataract of nuclear sclerosis grade 1 to 3 as measured by LOCS III grading system (patients with cortical or posterior subcapsular cataract of any grade will be eligible).
  • Patients must be able to provide written informed consent for participating in the study.
  • Preoperative best corrected visual acuity of 20/25 or worse.

Exclusion Criteria:

  • Patients with corneal edema, corneal guttata, pseudoexfoliation, zonular dialysis, or other ocular anomalies (e.g., inflammation, uveitis, previous trauma, suspected microbial infection, glaucoma, and macular disease).
  • Patients wearing soft contact lenses will need to discontinue lens wear for 2 weeks, and hard contact lens wearers for one month prior to intraocular lens measurements.
  • Women patients of childbearing potential.
  • Patients undergoing arcuate keratotomy or other combined surgery with cataract.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cataract removal with Zero CDE technique
This is a single-arm, non-comparative, prospective study including cataract patients with a nuclear sclerosis grade between 1 to 3 who desire to undergo cataract surgery and IOL implantation at Bochner Eye Institute, Canada.
Procedure: Femtosecond laser-assisted cataract surgery using Zero CDE
In this single-arm, non-comparative study, patients with cataract grade 1-3 (LOCS III nuclear sclerosis) will undergo cataract removal with the Zero CDE technique that involves no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% of cataract cases completed with Zero CDE
Time Frame: Intraoperative
Intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case.
Time Frame: Intraoperative
Intraoperative
Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop.
Time Frame: Postoperative Day 1
Postoperative Day 1
Among the cataract cases with zero CDE o % of cataract cases with CME at any time up to 3 months postop.
Time Frame: Postoperative 2 weeks, 1 month and 3 months
Postoperative 2 weeks, 1 month and 3 months
Among the cases requiring CDE, the amount of phaco energy used
Time Frame: Intraoperative
Intraoperative
Incidence of adverse events
Time Frame: Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months
Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bochner Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

March 14, 2027

Study Completion (Estimated)

July 14, 2027

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RS/2024/01 version 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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