Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection

Not Applicable

Completed

• Conditions: Intravitreal Injection; Subconjunctival Hemorrhage; Pain
• Interventions: Procedure: Cooled eye drops and povidone-iodine

• Registration Number: NCT04827836
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Status Verified: 2021-07
• Study Start: 2021-07-11
• Primary Completion: 2021-12-27
• Study Completion: 2021-12-27
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B - Cooled eye drops and povidone-iodine	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).

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 Holon, Hamerkaz, Israel