Adult Patients Undergoing Phacoemulsification With Topical Anesthesia
Conditions
Brief summary
This study aimed to compare the efficacy between 2% lidocaine gel vs 0.5% tetracaine eye drop as topical anesthesia in phacoemulsification
Detailed description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Lidocaine gel and tetracaine eye drop group). Lidocaine group received 2% lidocaine gel in 1 ml syringe, applied to the eye. Tetracaine group received 0.5% tetracaine eye drop. Topical anesthesia was given 5 minutes before phacoemulsification. Five minutes after phacoemulsification finished, visual analog score (VAS) and subjects and surgeon's satisfaction were assessed. Every additional topical anesthesia needed was recorded.
Interventions
DRUGlidocaine gel
2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification
DRUGtetracaine eye drop
0.5% tetracaine eye drop was given 5 minutes before phacoemulsification
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged more than 40 years old who were planned to undergo elective phacoemulsification with intraocular lens implantation at operating room. The surgery was operated by an experienced ophthalmologist. Subjects had been explained about the study, and agreed to enroll and have signed the informed consent form.
Exclusion criteria
* Subjects with history of allergy to topical anesthesia (2% lidocaine gel and 0.5% tetracaine eye drop), subjects who used another method of intraoperative anesthesia other than topical anesthesia, subjects with history of phacoemulsification before, subjects with difficulty in communication, dementia, and anxiety. Dropout Criteria: * Phacoemulsifications duration more than 30 minutes, and subjects who resigned from the study before the study ended
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale | Day 1 | assessing subject's pain with visual analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional topical anesthesia requirement | Day 1 | Number of additional topical anesthesia given after the first dose |
| Subjects and surgeon's satisfactory | Day 1 | Assessment is done using questionnaire |
Countries
Indonesia
Outcome results
None listed