CompletedNot Applicable

Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection

Israel100 participantsStarted 2021-07-11

Plain-language summary

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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Minute 1

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

Timeframe: Minute 10

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

Timeframe: Hour 2

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

Timeframe: Hour 24

Trial details

NCT IDNCT04827836

SponsorWolfson Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-12-27

View on ClinicalTrials.gov More Intravitreal Injection trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Minute 1

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

Timeframe: Minute 10

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

Timeframe: Hour 2

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

Timeframe: Hour 24