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Not yet recruiting NCT07404293

Zero CDE Technique for Lens Removal During FLACS

No phase Interventional Cataract With a Nuclear Sclerosis Grade Between 1 to 3

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Femtosecond laser-assisted cataract surgery using Zero CDE.
Who it may be relevant to
Registry conditions: Cataract With a Nuclear Sclerosis Grade Between 1 to 3. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • % of cataract cases completed with Zero CDE [Time frame: Intraoperative]
Secondary outcome measures (5)
  • Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case. [Time frame: Intraoperative]
  • Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop. [Time frame: 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]
  • Among the cases requiring CDE, the amount of phaco energy used [Time frame: Intraoperative]
  • Incidence of adverse events [Time frame: Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Bochner Eye Institute — Toronto

Identifiers

NCT: NCT07404293 · RS/2024/01 version 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗