Pain Clinical Trial
Official title:
Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection Using Cooled Anesthetic Eye Drops and Antiseptics: A Double-Blind Randomized Controlled Trial
Verified date | July 2021 |
Source | Wolfson Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intravitreal injections (IVI) are the mainstay of treatment modality in many ophthalmologic diseases including neovascular age-related macular degeneration (AMD), diabetic retinopathy and retinal vascular occlusions. Patients endure monthly IVI for several years. Although standardized topical anesthesia protocols are being carried out, many still suffer from pain during and after the procedure. Previous studies at the investigators clinic have demonstrated that alpha-agonist eye drops and cool eye compresses can be successfully used in order to reduce pain levels when administered prior to IVI. In the current research, the investigators wish to study whether cooled anesthetic eye drops and antiseptics can be utilized as well to reduce the pain and subconjunctival hemorrhage caused by bevacizumab IVI.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 27, 2021 |
Est. primary completion date | December 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Participants over the age of 18 years, receiving Bevacizumab IVI who are capable of signing a written informed consent form obtained under the Declaration of Helsinki. Exclusion Criteria: - No consent to participate in the study. - Incapability of signing a written informed consent form. |
Country | Name | City | State |
---|---|---|---|
Israel | Wolfson Medical Center | Holon | Hamerkaz |
Lead Sponsor | Collaborator |
---|---|
Wolfson Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ). | The VAS will be used to measure participant's discomfort, itching, burning, and pain (the VAS scale ranges from 0-10, '0' being no pain at all and '10' being the most severe pain). For each participant, tolerability score will be calculated by averaging the participant's discomfort, itching, burning, and pain. To estimate the participant's baseline pain scores, a self-reported pain sensitivity questionnaire, the PSQ, will be used prior to IVI. This is a validated 17-item questionnaire designed to assess an individual's baseline pain sensitivity. | Minute 1 | |
Primary | Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ). | The VAS will be used to measure participant's discomfort, itching, burning, and pain (the VAS scale ranges from 0-10, '0' being no pain at all and '10' being the most severe pain). For each participant, tolerability score will be calculated by averaging the participant's discomfort, itching, burning, and pain. To estimate the participant's baseline pain scores, a self-reported pain sensitivity questionnaire, the PSQ, will be used prior to IVI. This is a validated 17-item questionnaire designed to assess an individual's baseline pain sensitivity. | Minute 10 | |
Primary | Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ). | The VAS will be used to measure participant's discomfort, itching, burning, and pain (the VAS scale ranges from 0-10, '0' being no pain at all and '10' being the most severe pain). For each participant, tolerability score will be calculated by averaging the participant's discomfort, itching, burning, and pain. To estimate the participant's baseline pain scores, a self-reported pain sensitivity questionnaire, the PSQ, will be used prior to IVI. This is a validated 17-item questionnaire designed to assess an individual's baseline pain sensitivity. | Hour 2 | |
Primary | Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ). | The VAS will be used to measure participant's discomfort, itching, burning, and pain (the VAS scale ranges from 0-10, '0' being no pain at all and '10' being the most severe pain). For each participant, tolerability score will be calculated by averaging the participant's discomfort, itching, burning, and pain. To estimate the participant's baseline pain scores, a self-reported pain sensitivity questionnaire, the PSQ, will be used prior to IVI. This is a validated 17-item questionnaire designed to assess an individual's baseline pain sensitivity. | Hour 24 | |
Secondary | Participant's subconjunctival hemorrhage (SCH) size after intravitreal injection (IVI) as evaluated by a slit lamp examination. | SCH size following IVI will be photographed using a slit lamp camera at a uniform magnification and quantified using an image analysis software. | Minute 10 |
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