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Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection

NCT ID: NCT04827836

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-11

Study Completion Date

2021-12-27

Brief Summary

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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

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Conditions

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Intravitreal Injection Pain Subconjunctival Hemorrhage

Keywords

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Intravitreal injection Pain Subconjunctival Hemorrhage Bevacizumab Eye drops

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Cooled eye drops and povidone-iodine

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Oriel Spierer

Director of the Pediatric Ophthalmology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oriel Spierer, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

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Wolfson Medical Center

Holon, Central District, Israel

Site Status

Countries

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Israel

Other Identifiers

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0255-20-WOMC

Identifier Type: -

Identifier Source: org_study_id