UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063450 |
|---|---|
| Receipt number | R000072625 |
| Scientific Title | Effects of Aspiration Flow Rate on Corneal Endothelial Cell Loss and Postoperative Aqueous Flare in Eight-Chop Cataract Surgery: A Prospective Randomized Fellow-Eye Equivalence Trial |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/29 10:44:10 |
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Basic information
Public title
Effects of Aspiration Flow Rates of 32 and 40 mL/min on Corneal Endothelial Cell Loss and Postoperative Inflammation in Cataract Surgery
Acronym
Eight-Chop Flow Rate Equivalence Study
Scientific Title
Effects of Aspiration Flow Rate on Corneal Endothelial Cell Loss and Postoperative Aqueous Flare in Eight-Chop Cataract Surgery: A Prospective Randomized Fellow-Eye Equivalence Trial
Scientific Title:Acronym
Eight-Chop 32 vs. 40 mL/min Aspiration Flow Rate Equivalence Trial
Region
| Japan |
Condition
Condition
Senile cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate equivalence in corneal endothelial cell density loss at postoperative week 19 between aspiration flow settings of 32 and 40 mL/min during Eight-Chop phacoemulsification, using a prespecified equivalence margin of +/- 2.0 percentage points, and to compare postoperative aqueous flare and intraoperative parameters.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Equivalence of corneal endothelial cell density (CECD) loss (%) at 19 weeks postoperatively between aspiration flow rates of 32 and 40 mL/min, with a predefined equivalence margin of +/- 2.0 percentage points.
Key secondary outcomes
1. Aqueous flare at postoperative day 7 (ph/ms).
2. Aqueous flare at postoperative day 1, week 7, and week 19 (ph/ms).
3. Corneal endothelial cell density (CECD) loss (%) at postoperative week 7.
4. Intraoperative volume of fluid used (VFU, mL).
5. Intraoperative cumulative dissipated energy (CDE).
6. Intraoperative phacoemulsification time (seconds).
7. Intraoperative aspiration time (seconds).
8. Total operative time (minutes).
9. Incidence of intraoperative complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Aspiration flow rate of 32 mL/min. Eight-Chop phacoemulsification is performed using the Alcon Centurion system with a target intraocular pressure of 55 mmHg and a maximum vacuum of 500 mmHg. The intervention is applied once during cataract surgery in one eye. All other surgical settings and postoperative management are standardized between the two groups.
Interventions/Control_2
Aspiration flow rate of 40 mL/min. Eight-Chop phacoemulsification is performed using the Alcon Centurion system with a target intraocular pressure of 55 mmHg and a maximum vacuum of 500 mmHg. The intervention is applied once during cataract surgery in the fellow eye. All other surgical settings and postoperative management are standardized between the two groups.
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
1. Patients aged 50 to 90 years, inclusive.
2. Patients with bilateral age-related cataracts scheduled for cataract surgery in both eyes.
3. Patients with Emery-Little nuclear sclerosis Grade II or III in both eyes.
4. Patients with preoperative corneal endothelial cell density of at least 1800 cells/mm2 in both eyes.
5. Patients available for postoperative follow-up through week 19.
6. Patients who provide written informed consent after receiving an explanation of the study.
Key exclusion criteria
1. Patients with diabetes mellitus.
2. Eyes with Emery-Little nuclear sclerosis Grade I or Grade IV or higher.
3. Eyes with corneal endothelial cell density below 1800 cells/mm2.
4. Patients with corneal disease, uveitis, glaucoma, or other ocular conditions that may affect the study outcomes.
5. Eyes with a history of intraocular surgery.
6. Eyes with traumatic or complicated cataracts.
7. Patients requiring additional intraocular surgery combined with cataract surgery.
8. Patients considered unsuitable for participation by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sato |
Organization
Sato Eye Clinic
Division name
Department of Ophthalmology
Zip code
2710077
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
2710077
Address
Nemoto 3-3, Matsudo-shi 271-0077, Chiba-ken, Japan
TEL
0477029822
Homepage URL
perfect-eightchop@sato-ganka.com
Sponsor or person
Institute
Sato Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Sato Eye Clinic
Organization
Division
Category of Funding Organization
Other
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
0477029822
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
| 2026 | Year | 11 | 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
| 2026 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072625
