Zero CDE Technique for Lens Removal During FLACS

NCT07404293 | Not Yet Recruiting

• 1 other identifier: RS/2024/01 version 2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cataract With a Nuclear Sclerosis Grade Between 1 to 3

Keywords

Zero CDE technique; FLACS

Outcome Measures

Primary Outcomes (1)

• % of cataract cases completed with Zero CDE

  Intraoperative

Secondary Outcomes (5)

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

  Intraoperative

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

  Postoperative Day 1

• Among the cataract cases with zero CDE o % of cataract cases with CME at any time up to 3 months postop.

  Postoperative 2 weeks, 1 month and 3 months

• Among the cases requiring CDE, the amount of phaco energy used

  Intraoperative

• Incidence of adverse events

  Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months

Study Arms (1)

Cataract removal with Zero CDE technique

EXPERIMENTAL

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

Interventions

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.

Cataract removal with Zero CDE technique

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bochner Eye Institute: lead

Study Sites (1)

Bochner Eye Institute

Toronto, Ontario, M5R1A9, Canada

Location

Central Study Contacts

Raymond Stein, MD, FRCSC

CONTACT

416-569-3806; raymondmstein@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): July 14, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)