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NCT Number: NCT07404293

Zero CDE Technique for Lens Removal During FLACS

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).

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Key information

Conditions

Cataract With a Nuclear Sclerosis Grade Between 1 to 3

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Femtosecond laser-assisted cataract surgery using Zero CDE

Procedure

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.

Primary outcomes

  1. % of cataract cases completed with Zero CDE

    Time frame: Intraoperative

Secondary outcomes

  1. Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case.

    Time frame: Intraoperative

  2. Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop.

    Time frame: Postoperative Day 1

  3. 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

  4. Among the cases requiring CDE, the amount of phaco energy used

    Time frame: Intraoperative

  5. Incidence of adverse events

    Time frame: Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Stein, MD, FRCSC

CONTACT

[email protected]

416-569-3806

Sponsors and collaborators

Lead sponsor

Bochner Eye Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

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.