Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection

Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection Using Cooled Anesthetic Eye Drops and Antiseptics: A Double-Blind Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Intravitreal Injection; Subconjunctival Hemorrhage
• Intervention / Treatment: Procedure: Cooled eye drops and povidone-iodine

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hamerkaz
    • Holon, Hamerkaz, Israel, 5822012
      • Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Cohort A - Room-temperature eye drops and povidone-iodine; Participants will receive a standardized topical anesthesia protocol of oxybuprocaine hydrogen chloride (HCl) 0.4% and lidocaine HCl 2% eye drops. Each drop will be instilled 3 times (one drop): At 10 minutes, 5 minutes, and just before the injection. Before the injection patients will receive cul-de-sac 5% povidone-iodine (3 drops) and the peri-ocular skin will be disinfected using a 10% povidone-iodine. A standard intravitreal injection of bevacizumab, 1.25 mg/0.05 ml will be performed through the pars plana with a 30-gauge needle, 3.5 mm from the corneal limbus, at the superior-temporal quadrant. Following the injection, a cotton swab absorbed with 5% povidone-iodine will be applied to the injection site.
Experimental: Cohort B - Cooled eye drops and povidone-iodine; Participants will receive the same treatment as cohort A, using cooled eye drops and povidone-iodine (5 degree Celsius).	Procedure: Cooled eye drops and povidone-iodine; Cooled oxybuprocaine HCl 0.4% and lidocaine HCl 2% eye drops and cooled povidone-iodine (cul-de-sac 5% povidone-iodine and 10% povidone-iodine).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Oriel Spierer, MD, Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2021
• Primary Completion (Actual): December 27, 2021
• Study Completion (Actual): December 27, 2021

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Bevacizumab; Intravitreal injection; Eye drops; Subconjunctival Hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Plasma Substitutes; Blood Substitutes; Ophthalmic Solutions; Povidone-Iodine; Povidone
• Other Study ID Numbers: 0255-20-WOMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No