UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059907 |
|---|---|
| Receipt number | R000068377 |
| Scientific Title | Prospective comparative study evaluating surgical efficiency and endothelial cell loss between the eight-chop technique and other nucleus disassembly techniques in phacoemulsification cataract surgery |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/27 21:39:52 |
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Basic information
Public title
Prospective comparative study evaluating surgical efficiency and endothelial cell loss between the eight-chop technique and other nucleus disassembly techniques in phacoemulsification cataract surgery
Acronym
Prospective comparative study evaluating surgical efficiency and endothelial cell loss between the eight-chop technique and other nucleus disassembly techniques in phacoemulsification cataract surgery
Scientific Title
Prospective comparative study evaluating surgical efficiency and endothelial cell loss between the eight-chop technique and other nucleus disassembly techniques in phacoemulsification cataract surgery
Scientific Title:Acronym
Prospective comparative study evaluating surgical efficiency and endothelial cell loss between the eight-chop technique and other nucleus disassembly techniques in phacoemulsification cataract surgery
Region
| Japan |
Condition
Condition
age-related cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively evaluate surgical efficiency, intraoperative parameters, and postoperative corneal endothelial safety of the eight-chop technique compared with other nucleus disassembly techniques (including phaco-chop and prechop) across a broad range of lens hardness (Emery-Little II-IV) in phacoemulsification cataract surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change rate in corneal endothelial cell density (change rate at 19 weeks post-surgery relative to pre-surgery)
*Long-term follow-up evaluations at 52 weeks, 104 weeks, etc., may be added in the future.
Key secondary outcomes
1. CDE (Cumulative Dissipated Energy)
2. Effective Ultrasound Time (EPT)
3. Irrigation Fluid Volume
4. Suction time
5. Intraoperative complications
6. Postoperative anterior chamber flare value
7. Corneal thickness changes
8. Visual acuity (BCVA)
9. Correlation between intraoperative fluid settings (IOP, flow, vacuum) and ECL%
10. Subgroup analysis by nucleus hardness and surgical technique
11. Endothelial cell loss rate in long-term follow-up (up to 5 years)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standard phacoemulsification cataract surgery using established nucleus disassembly techniques, including phaco-chop and/or prechop techniques. Machine settings, ophthalmic viscosurgical devices, and intraocular lens models will be kept as consistent as possible with the intervention arm. All surgeries will be performed by the same experienced surgeon. This arm serves as the active control group.
Interventions/Control_2
Standard phacoemulsification cataract surgery using established nucleus disassembly techniques, including phaco-chop and/or prechop techniques. Machine settings, ophthalmic viscosurgical devices, and intraocular lens models will be kept as consistent as possible with the intervention arm. All surgeries will be performed by the same experienced surgeon. This arm serves as the active control group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 50 years or older with age-related cataract.
Lens nucleus hardness graded II to IV according to the Emery-Little classification.
Preoperative corneal endothelial cell density >= 1800 cells/mm2, with reliable and reproducible specular microscopy measurements.
Ability to comply with all scheduled pre- and postoperative examinations, including visual acuity, corneal endothelial cell density, and anterior chamber flare measurements.
Absence of any ocular or systemic conditions that may interfere with the evaluation of surgical outcomes.
Written informed consent obtained after receiving a full explanation of the study procedures, risks, and benefits.
Key exclusion criteria
Eyes with traumatic, congenital, or secondary cataracts other than age-related cataracts
Eyes with corneal diseases such as corneal degeneration, corneal dystrophy, corneal opacity, or Fuchs endothelial corneal dystrophy
Preoperative corneal endothelial cell density < 1800 cells/mm2 or unreliable measurements
History of intraocular surgery or ocular laser procedures (e.g., LASIK, PRK, SLT, glaucoma surgery) in the study eye
Severe amblyopia, active ocular inflammation, or ocular surface disorders (e.g., severe dry eye) that may interfere with postoperative evaluation
Eyes with coexisting ocular diseases such as glaucoma, diabetic retinopathy, or significant macular diseases (AMD, macular hole, epiretinal membrane, etc.)
Eyes requiring combined surgery other than intraocular lens implantation (e.g., glaucoma surgery, vitrectomy)
Eyes or patients with uncontrolled intraocular pressure, optic nerve disorders, or systemic conditions that substantially increase surgical risk
Patients unable to comply with the scheduled examinations or follow-up visits
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sato |
Organization
Sato Eye Clinic
Division name
Director
Zip code
271-0077
Address
Nemoto 3-3, Matsudo-shi 271-0077, Chiba-ken, Japan
TEL
0477029822
perfect-eightchop@sato-ganka.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sato |
Organization
Sato Eye Clinic
Division name
Director
Zip code
271-0077
Address
Nemoto 3-3, Matsudo-shi 271-0077, Chiba-ken, Japan
TEL
047-702-9822
Homepage URL
perfect-eightchop@sato-ganka.com
Sponsor or person
Institute
Sato Eye Clinic
Institute
Department
Personal name
Tsuyoshi Sato
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sato Eye Clinic
Address
Nemoto 3-3, Matsudo-shi 271-0077, Chiba-ken, Japan
Tel
047-702-9822
perfect-eightchop@sato-ganka.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068377
