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NCT Number: NCT04827836

Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection

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.

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Key information

Conditions

Intravitreal Injection Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Subconjunctival Hemorrhage

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wolfson Medical Center

Holon, Central District, 5822012, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cooled eye drops and povidone-iodine

Procedure

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).

Primary outcomes

  1. Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).

    Time frame: Minute 1

    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.

  2. Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).

    Time frame: Minute 10

    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.

  3. Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).

    Time frame: Hour 2

    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.

  4. Participant's discomfort after intravitreal injection (IVI) as assessed by the visual analog scale (VAS) and pain sensitivity questionnaire (PSQ).

    Time frame: Hour 24

    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.

Secondary outcomes

  1. Participant's subconjunctival hemorrhage (SCH) size after intravitreal injection (IVI) as evaluated by a slit lamp examination.

    Time frame: Minute 10

    SCH size following IVI will be photographed using a slit lamp camera at a uniform magnification and quantified using an image analysis software.

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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