Nuclear CataractNCT05736042
Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery
A study testing Lens fragmentation in people with Nuclear Cataract, run by Oogziekenhuis Rotterdam at 1 site in Netherlands.
Trial summary
Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nuclear Cataract
- What is being tested?
- Lens fragmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Apr 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Informed consent.
- Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III).
Who cannot join
- Endothelial cell density (ECD) < 1500 mm-2.
- Corneal opacification (any cause).
- Corneal surgery or trauma.
- Implant lens.
- Refraction surgery.
- Prior glaucoma surgery.
- Pseudoexfoliation.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Oogziekenhuis Rotterdam
Rotterdam
Oogziekenhuis Rotterdam
Bart Zijlmans
About this study
Official title: Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery Versus Conventional Phacoemulsification Using Divide-and-conquer: a Randomized Controlled Trial
Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Recently, it was demonstrated that with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced.
Objective: To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells.
Study design: Randomized, controlled trial. Study population: Patients with nuclear cataract of a grade ≥ 5. Intervention: Microinterventional endocapsular nuclear fragmentation. Main study parameters: Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.
- Conditions
- Nuclear Cataract
- Being tested
- Lens fragmentation
- Keywords
- LOCS III grade 5 or more
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens fragmentationDevice
Lens fragmentation with the microinterventional microfilament loop device (miLOOP)
| Study group | Role | What they receive |
|---|---|---|
| Lens fragmentation with miLOOP | Experimental | Phacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP) Receives: Device: Lens fragmentation |
| Controls | No intervention | Phacoemulsification alone (no adjunctive lens fragmentation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound cumulative dispersed energy (CDE)
Phaco energy (Centurion, Alcon)
Measured: During surgery
Change of corneal endothelial cell density (ECD)
Central cell density will be assessed
Measured: Preoperative and at 3 months
Secondary outcomes (3)
Procedure time
Total sugery time
Measured: During surgery
Peri-operative complications
Any complications during surgery
Measured: During surgery
Postoperative complications
Any complications after surgery
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start3 Apr 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nuclear CataractStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oogziekenhuis Rotterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis Prof.dr H.J. Flieringa, Carl Zeiss Meditec AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736042
- Sponsor's protocol ID
- OZR-2022-07
- Other IDs
- NL83139.078.22
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 Apr 2023
- 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery Versus Conventional Phacoemulsification Using Divide-and-conquer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05736042
- Acronym / sponsor ID
- OZR-2022-07
- Conditions
- Nuclear Cataract
- Keywords
- LOCS III grade 5 or more
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oogziekenhuis RotterdamUniversity, hospital or other
- Collaborators
- Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis Prof.dr H.J. Flieringa, Carl Zeiss Meditec AG
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 21 Feb 2023 (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.
Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Recently, it was demonstrated that with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced.
Objective: To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells.
Study design: Randomized, controlled trial. Study population: Patients with nuclear cataract of a grade ≥ 5. Intervention: Microinterventional endocapsular nuclear fragmentation. Main study parameters: Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens fragmentation with miLOOP | Experimental | Device: Lens fragmentationPhacoemulsification with adjunctive lens fragmentation with the microinterventional microfilament loop device (miLOOP) |
| Controls | No intervention | –Phacoemulsification alone (no adjunctive lens fragmentation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Informed consent.
- Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III).
Key exclusion criteria (7 listed)
- Endothelial cell density (ECD) < 1500 mm-2.
- Corneal opacification (any cause).
- Corneal surgery or trauma.
- Implant lens.
- Refraction surgery.
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 |
|---|---|---|
| Lens fragmentationLens fragmentation with the microinterventional microfilament loop device (miLOOP) | Device | Lens fragmentation with miLOOP |
Primary outcome
Ultrasound cumulative dispersed energy (CDE)
Time frame: During surgery
Phaco energy (Centurion, Alcon)
Change of corneal endothelial cell density (ECD)
Time frame: Preoperative and at 3 months
Central cell density will be assessed
3 secondary outcomes
Procedure time
Time frame: During surgery
Peri-operative complications
Time frame: During surgery
Postoperative complications
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens fragmentation in people with Nuclear Cataract, run by Oogziekenhuis Rotterdam at 1 site in Netherlands.
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 7 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rene Wubbels (+31104023430, r.wubbels@oogziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound cumulative dispersed energy (CDE) (time frame: During surgery). The study lists 2 primary outcomes in all. 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 10 Apr 2023.