Cataract With a Nuclear Sclerosis Grade Between 1 to 3NCT07404293
Zero CDE Technique for Lens Removal During FLACS
A study testing Femtosecond laser-assisted cataract surgery using Zero CDE in people with Cataract With a Nuclear Sclerosis Grade Between 1 to 3, run by Bochner Eye Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract With a Nuclear Sclerosis Grade Between 1 to 3
- What is being tested?
- Femtosecond laser-assisted cataract surgery using Zero CDE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2026to 14 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Bochner Eye Institute
Toronto, Ontario, M5R1A9
Raymond Stein, MD, FRCSC, 416-569-3806, raymondmstein@gmail.com
About this study
Official title: 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).
- Being tested
- Femtosecond laser-assisted cataract surgery using Zero CDE
- Keywords
- Zero CDE technique, FLACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond laser-assisted cataract surgery using Zero CDEProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Femtosecond laser-assisted cataract surgery using Zero CDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of cataract cases completed with Zero CDE
Measured: Intraoperative
Secondary outcomes (5)
Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case.
Measured: Intraoperative
Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop.
Measured: Postoperative Day 1
Among the cataract cases with zero CDE o % of cataract cases with CME at any time up to 3 months postop.
Measured: Postoperative 2 weeks, 1 month and 3 months
Among the cases requiring CDE, the amount of phaco energy used
Measured: Intraoperative
Incidence of adverse events
Measured: Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion14 Mar 2027 (estimated)
- Study completion14 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract With a Nuclear Sclerosis Grade Between 1 to 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bochner Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Stein, Bochner Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404293
- Sponsor's protocol ID
- RS/2024/01 version 2
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero CDE Technique for Lens Nucleus Removal During Femtosecond Laser-Assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT07404293
- Acronym / sponsor ID
- RS/2024/01 version 2
- Keywords
- Zero CDE technique, FLACS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bochner Eye InstituteUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 14 Jul 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract removal with Zero CDE technique | Experimental | Procedure: Femtosecond laser-assisted cataract surgery using Zero CDEThis 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 may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femtosecond laser-assisted cataract surgery using Zero CDEIn 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. | Procedure or surgery | Cataract removal with Zero CDE technique |
Primary outcome
% of cataract cases completed with Zero CDE
Time frame: Intraoperative
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond laser-assisted cataract surgery using Zero CDE in people with Cataract With a Nuclear Sclerosis Grade Between 1 to 3, run by Bochner Eye Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Stein, MD, FRCSC (416-569-3806, raymondmstein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of cataract cases completed with Zero CDE (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.