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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03143452 |
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Date of registration:
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04/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification
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Scientific title:
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Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification |
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Date of first enrolment:
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December 1, 2016 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03143452 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adult Patients Undergoing Phacoemulsification With Topical Anesthesia
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Intervention(s)
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Drug: lidocaine gel
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Drug: tetracaine eye drop
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Primary Outcome(s)
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Visual analog scale
[Time Frame: Day 1]
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Secondary Outcome(s)
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Subjects and surgeon's satisfactory
[Time Frame: Day 1]
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Additional topical anesthesia requirement
[Time Frame: Day 1]
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Secondary ID(s)
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IndonesiaUAnes015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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