Binocular cataracts(scheduled for phacoemulsification-aspiration ultrasound and lens reconstraction)
Conditions
Interventions
Randomly assign one eye to a perfusion pressure close to normal IOP (low IOP: 20 mmHg) and the other eye to the conventionally set standard irrigation pressure (high IOP: 50 mmHg) during cataract surg
Sponsors
Satoh Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those diagnosed with bilateral cataracts and scheduled to undergo phacoemulsification-aspiration and lens reconstruction 2) Persons with an ocular axis length of 26 mm or more in both eyes 3) Persons with a nuclear hardness of grade 2 or 3 according to the Emery Little classification 4) Men and women aged 40 and over at the time of obtaining consent 5) Persons who understand the explanatory document and give written consent of their own free will
Exclusion criteria
Exclusion criteria: 1) History of ophthalmic surgery, including corneal refractive surgery 2) Persons with mental illness or dementia 3) Persons using analgesics, narcotics or benzodiazepines 4) Other persons who are judged by the principal investigator or others to be unsuitable as subjects of the study, for reasons such as accompanying systemic or ophthalmological diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of test eyes with additional local anaesthetic for discomfort/pain during cataract surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Surgeons' scores for patients' surgical co-operation 2) Intraoperative discomfort/pain scores by patients (at the start of phacoemulsification/aspiration, at the start of I/A, during OVD removal and throughout surgery) 3) Parameters during cataract surgery (CDE/BSS usage/Aspiration time/Ultrasound time/Case Time/ASM activation) 4) Safety endpoints: adverse events / malfunction of medical equipment | — |
Contacts
Public ContactHiroyuki Satoh
Yuya Satoh Eye Clinic
Outcome results
None listed