Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection

Wolfson Medical Center (WMC)

Status: Completed

Conditions: Intravitreal Injection; Subconjunctival Hemorrhage; Pain

Treatments: Procedure: Cooled eye drops and povidone-iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT04827836

0255-20-WOMC

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Cohort A - Room-temperature eye drops and povidone-iodine

No Intervention group

Description:

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.

Cohort B - Cooled eye drops and povidone-iodine

Experimental group

Description:

Participants will receive the same treatment as cohort A, using cooled eye drops and povidone-iodine (5 degree Celsius).

Treatment:

Procedure: Cooled eye drops and povidone-iodine