Hard Nuclear CataractNCT06991374
Study on the Surgical Strategy of Corneal Endothelial Protection for Hard Nuclear Cataract Patients
A study testing combined burst mode and torsional mode in people with Hard Nuclear Cataract and Phacoemulsification Cataract Surgery, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
In this study, we compared two types of phacoemulsification commonly used in cataract surgery to evaluate their effect on the prognosis of patients with hard nuclei. This will provide a theoretical basis for selecting a more appropriate cataract surgery modality in practice in hard-nucleus patients. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Hard Nuclear Cataract, Phacoemulsification Cataract Surgery, Endothelial Cell Density Loss
- What is being tested?
- combined burst mode and torsional mode
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 1 Mar 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with age-related cataracts that were only classified by Emery-Little as nuclear hardness grade III-V.
- encompassed a minimum dilated pupil diameter of 7 mm or above, as well as a corneal endothelial cell count exceeding 1200/mm^2.
- Corneal morphology is normal and clear
- Informed consent is required prior to enrollment
Who cannot join
- Those with white cataracts, histories of eye surgery, and eye diseases such as corneal pathology, uveitis, Fuchs\' dystrophy, and glaucoma were excluded.
- Exclude those with comorbid ocular and systemic diseases that affect corneal endothelial cell function
- Exclude those with previous intraocular surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Eye and ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Combined Burst Mode Versus Torsional Mode Phacoemulsification for Patients With Hard Nuclear Cataract: A Randomized Control Study
In this study, we compared two types of phacoemulsification commonly used in cataract surgery to evaluate their effect on the prognosis of patients with hard nuclei. This will provide a theoretical basis for selecting a more appropriate cataract surgery modality in practice in hard-nucleus patients.
Read the detailed description
In this study, we randomized patients into two groups. One group was the combined mode group in burst mode and the other group was the torsional ultrasound group in continuous mode. Cumulative dissipated energy(CDE) and ultrasound time(UST) were recorded during the procedure. Changes in central cornea thickness(CCT) and endothelial cell density(ECD) of the patients were recorded postoperatively during a 3-month follow-up. Intraoperative and postoperative complications were also recorded. The above data were analyzed to compare the effect of both on postoperative corneal recovery in patients with hard nuclei.
- Conditions
- Hard Nuclear Cataract, Phacoemulsification Cataract Surgery, Endothelial Cell Density Loss, Central Corneal Thickness
- Being tested
- combined burst mode, torsional mode
- Keywords
- Hard nuclear cataract, phacoemulisification mode, ultrasound time, cumulative dissipated energy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined burst modeProcedure or surgery
the combined burst mode is commonly used in cataract phacoemulsification. This study compares whether the two modes have different outcomes in hard nuclear cataract surgery.
torsional modeProcedure or surgery
the toesional mode is commonly used in cataract phacoemulsification. This study compares whether the two modes have different outcomes in hard nuclear cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Combined burst mode | Experimental | combining the torsional and vertical ultrasound under burst mode(Burst Tor+ Burst US) Phacoemulsification mode Brust mode Torsional amplitude 0-90% Longitudinal power 40% Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration 70 ms Off time 50 ms Receives: Procedure: combined burst mode |
| torsional mode | Active comparator | torsional mode under continues mode (Linear Tor) Phacoemulsification mode Continuous mode Torsional amplitude 0-90% Longitudinal power 0 Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration - Off time - Receives: Procedure: torsional mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell density
Endothelial cell density after cataract surgery.
Measured: At 1day, 1week, 1month, 3months postoperatively.
central cornea thickness
central cornea thickness after cataract surgery.
Measured: At 1day, 1week, 1month, 3months postoperatively.
ultrasound time
ultrasound time during phacoemulsification.
Measured: During cataract surgery
cumulative dissipated energy
cumulative dissipated energy during phacoemulsification.
Measured: During cataract surgery
Secondary outcomes (3)
best-corrected distance visual acuity
best-corrected distance visual acuity after cataract surgery
Measured: At 1day, 1week, 1month, 3months postoperatively.
cornea edema
cornea edema after cataract surgery
Measured: At 1day, 1week, 1month, 3months postoperatively.
occlusion
occlusion during phacoemulsification
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start10 Aug 2022
- Primary completion25 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hard Nuclear CataractStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Model description
- all individuals scheduled for cataract surgery were randomly allocated to either the combined mode group (Burst Tor+ Burst US, Group A) or the torsional mode group (Linear Tor, Group B), utilizing an online random number generator.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yinghong Ji, Phd, Principal investigator, Eye & ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991374
- Sponsor's protocol ID
- 2013021
- Other IDs
- Grant No. 81770907 & No. 82070
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan, and Informed Consent Form will be shared.
Publications
Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
PubMed 17276271Ainiwaer M, Hong Y, Xiao B, Sun Y, Zhang S, Ning L, Liu H, Zhu X, Ji Y. Combined Burst Mode versus Torsional Mode Phacoemulsification for Patients with Hard Nuclear Cataracts: A Prospective Comparative Cohort Study. Clin Ophthalmol. 2026 Mar 13;20:587531. doi: 10.2147/OPTH.S587531. eCollection 2026.
PubMed 41852705
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Burst Mode Versus Torsional Mode Phacoemulsification for Patients With Hard Nuclear Cataract: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT06991374
- Acronym / sponsor ID
- 2013021
- Conditions
- Hard Nuclear Cataract, Phacoemulsification Cataract Surgery, Endothelial Cell Density Loss, Central Corneal Thickness
- Keywords
- Hard nuclear cataract, phacoemulisification mode, ultrasound time, cumulative dissipated energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 28 May 2025 (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.
In this study, we compared two types of phacoemulsification commonly used in cataract surgery to evaluate their effect on the prognosis of patients with hard nuclei. This will provide a theoretical basis for selecting a more appropriate cataract surgery modality in practice in hard-nucleus patients.
Detailed description
In this study, we randomized patients into two groups. One group was the combined mode group in burst mode and the other group was the torsional ultrasound group in continuous mode. Cumulative dissipated energy(CDE) and ultrasound time(UST) were recorded during the procedure. Changes in central cornea thickness(CCT) and endothelial cell density(ECD) of the patients were recorded postoperatively during a 3-month follow-up. Intraoperative and postoperative complications were also recorded. The above data were analyzed to compare the effect of both on postoperative corneal recovery in patients with hard nuclei.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- all individuals scheduled for cataract surgery were randomly allocated to either the combined mode group (Burst Tor+ Burst US, Group A) or the torsional mode group (Linear Tor, Group B), utilizing an online random number generator.
| Arm | Type | Receives |
|---|---|---|
| Combined burst mode | Experimental | Procedure: combined burst modecombining the torsional and vertical ultrasound under burst mode(Burst Tor+ Burst US) Phacoemulsification mode Brust mode Torsional amplitude 0-90% Longitudinal power 40% Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration 70 ms Off time 50 ms |
| torsional mode | Active comparator | Procedure: torsional modetorsional mode under continues mode (Linear Tor) Phacoemulsification mode Continuous mode Torsional amplitude 0-90% Longitudinal power 0 Infusion system Gravity fed Bottle height 50-80 cm Vacuum 360 mmHg Aspiration flow rate 30 cm3/min Burst duration - Off time - |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with age-related cataracts that were only classified by Emery-Little as nuclear hardness grade III-V.
- encompassed a minimum dilated pupil diameter of 7 mm or above, as well as a corneal endothelial cell count exceeding 1200/mm^2.
- Corneal morphology is normal and clear
- Informed consent is required prior to enrollment
Key exclusion criteria (3 listed)
- Those with white cataracts, histories of eye surgery, and eye diseases such as corneal pathology, uveitis, Fuchs\' dystrophy, and glaucoma were excluded.
- Exclude those with comorbid ocular and systemic diseases that affect corneal endothelial cell function
- Exclude those with previous intraocular 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 |
|---|---|---|
| combined burst modethe combined burst mode is commonly used in cataract phacoemulsification. This study compares whether the two modes have different outcomes in hard nuclear cataract surgery. | Procedure or surgery | Combined burst mode |
| torsional modethe toesional mode is commonly used in cataract phacoemulsification. This study compares whether the two modes have different outcomes in hard nuclear cataract surgery. | Procedure or surgery | torsional mode |
Primary outcome
Endothelial cell density
Time frame: At 1day, 1week, 1month, 3months postoperatively.
Endothelial cell density after cataract surgery.
central cornea thickness
Time frame: At 1day, 1week, 1month, 3months postoperatively.
central cornea thickness after cataract surgery.
ultrasound time
Time frame: During cataract surgery
ultrasound time during phacoemulsification.
cumulative dissipated energy
Time frame: During cataract surgery
cumulative dissipated energy during phacoemulsification.
3 secondary outcomes
best-corrected distance visual acuity
Time frame: At 1day, 1week, 1month, 3months postoperatively.
cornea edema
Time frame: At 1day, 1week, 1month, 3months postoperatively.
occlusion
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Results publication: PubMed 17276271Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
- Derived from this study: PubMed 41852705Ainiwaer M, Hong Y, Xiao B, Sun Y, Zhang S, Ning L, Liu H, Zhu X, Ji Y. Combined Burst Mode versus Torsional Mode Phacoemulsification for Patients with Hard Nuclear Cataracts: A Prospective Comparative Cohort Study. Clin Ophthalmol. 2026 Mar 13;20:587531. doi: 10.2147/OPTH.S587531. eCollection 2026.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan, and Informed Consent Form will be shared.
Related trials for Hard Nuclear Cataract
RecruitingPhase 2
A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
Corneal Endothelial Cell Loss, Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
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.
Yinghong Ji, Phd principal investigator
Eye & ENT Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined burst mode and torsional mode in people with Hard Nuclear Cataract and Phacoemulsification Cataract Surgery, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 28 May 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell density (time frame: At 1day, 1week, 1month, 3months postoperatively.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06991374, which also lists 2 linked publications.
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 28 May 2025.