Zero CDE Technique for Cataracts

Overseen By Raymond Stein, MD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bochner Eye Institute

Disqualifiers: Corneal edema, Glaucoma, Macular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for cataract removal using the Zero CDE Technique, which minimizes energy use to promote safer and quicker recovery. A special laser breaks up the cloudy lens in the eye, facilitating removal without generating extra heat. The trial seeks participants over 50 who require cataract surgery, particularly those whose vision remains poor even with glasses. This study may be suitable for individuals with bothersome cataracts, provided they do not have certain eye conditions like glaucoma or corneal issues. As an unphased trial, it offers a unique opportunity to contribute to innovative cataract treatment research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you wear contact lenses, you will need to stop wearing them for a period before certain measurements.

What prior data suggests that the Zero CDE technique is safe for cataract removal?

Research shows that the Zero CDE technique, used in femtosecond laser-assisted cataract surgery (FLACS), is very safe. Studies comparing this technique to traditional methods have found it has a low rate of complications and maintains eye stability during surgery, reducing patient risks.

One study indicated that this technique is as safe as the standard divide-and-conquer method, suggesting similar safety levels with the Zero CDE technique. Additionally, the femtosecond laser used in this technique is known for its accuracy, which helps reduce complications.

Overall, evidence suggests that the Zero CDE technique is well-tolerated by patients, with few negative effects reported. For those considering joining a clinical trial, existing research offers reassuring insights into its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Zero CDE Technique is unique because it aims to simplify cataract surgery by minimizing or eliminating the use of ultrasound energy, which is typically needed to break up the cloudy lens. Traditional cataract surgeries often rely on this ultrasound energy, which can sometimes cause heat-related damage to the eye tissue. Researchers are excited about this technique because it has the potential to make the procedure safer and gentler on the eye, reducing the risk of complications and improving recovery times for patients.

What evidence suggests that the Zero CDE technique is effective for cataract removal?

Research has shown that the Zero CDE technique in cataract surgery can be very effective. One study found that using a special laser to break up the cataract into small pieces allows for removal with less energy, leading to fewer complications. Another study demonstrated an 84.6% reduction in the time needed for ultrasound during surgery, suggesting the procedure might be quicker and safer. These findings indicate that the Zero CDE technique could help people recover faster and achieve better results after cataract surgery. Participants in this trial will undergo cataract removal using the Zero CDE technique to evaluate its effectiveness and safety. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with cataracts, a clouding of the lens in the eye. Participants should be suitable candidates for femtosecond laser-assisted cataract surgery (FLACS). Specific inclusion and exclusion criteria are not provided but would typically involve age, general health status, and specific characteristics of the cataract.

Inclusion Criteria

Preoperative best corrected visual acuity of 20/25 or worse

I am over 50 and have a certain type of cataract that can be operated on.

Patients must be able to provide written informed consent for participating in the study

Exclusion Criteria

I will stop wearing soft contact lenses 2 weeks or hard lenses 1 month before lens measurements.

I am a woman who can become pregnant.

I have eye conditions like corneal swelling, glaucoma, or previous eye injuries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Cataract removal using the Zero CDE technique with femtosecond laser-assisted surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after cataract surgery

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Zero CDE Technique

Trial Overview

The study tests a new technique called Zero CDE during FLACS to remove cataracts using minimal or no phaco energy. The goal is to see if pre-dividing the lens with a laser can improve outcomes like stable eye chambers, fewer complications, and quicker vision recovery.

How Is the Trial Designed?

Group I: Cataract removal with Zero CDE technique Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Bochner Eye Institute

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07404293

Zero CDE Technique for Lens Removal During FLACS

This prospective study aims to document the outcomes with the zero CDE technique during femtosecond laser-assisted cataract surgery (FLACS).

2.

withpower.com

withpower.com/trial/phase-cataract-with-a-nuclear-sclerosis-grade-between-1-to-3-2-2026-c37a0

Zero CDE Technique for Cataracts · Info for Participants

This prospective study aims to document the outcomes with the zero CDE technique during femtosecond laser-assisted cataract surgery (FLACS).

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2720679/

A retrospective randomized study to compare the energy ...

This study introduces the CDE as a measurement of surgical efficiency in hope of improving surgical outcomes. CDE data is not currently widely utilized for this ...

4.

nature.com

nature.com/articles/srep18684

Femtosecond laser combined with non-chopping rotation ...

Patients were followed up at 1, 7 and 30 days after surgery. There was an 84.6% and a 63.34% reduction in ultrasound time and cumulative ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9928072/

Outcomes of Femtosecond Laser Assisted Cataract Surgery ...

This study provides early evidence of safety, efficacy, and good visual outcomes of resident FLACS, a crucial first step in helping support and build larger ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10315025/

Safety and efficacy of cataract surgery performed with a low ...

To compare the safety and efficacy of femtosecond laser-assisted cataract surgery (FLACS) performed with the low-energy FEMTO LDV Z8 (Ziemer ...

7.

nature.com

nature.com/articles/s41598-025-13174-1

Femtosecond laser-assisted cataract surgery versus ...

The study aims to compare the efficacy/safety of femtosecond laser-assisted cataract surgery (FLACS) vs. conventional phacoemulsification ...

8.

healio.com

healio.com/news/ophthalmology/20151110/zero-energy-phaco-possible-without-a-laser

Zero energy phaco possible without a laser

In our practice, this technique was readily teachable to residents and found to be as equally safe as the standard divide-and-conquer technique.