The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections

Diabetic Macular Edema Clinical Trial

Official title:

The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615805
• Other study ID #: IRB #9810
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections.

Description:

Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI) application for intravitreal injections (IVI) affects patients' ocular surface irritation.

Methods This was a prospective, single-masked, randomized-controlled trial consisting of 142 subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours post-injection, were analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: October 1, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

choroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.

Exclusion Criteria:

active ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Cystoid Macular Edema
• Diabetic Macular Edema
• Edema
• Intravitreal Injection
• Macular Degeneration
• Macular Edema

Intervention

Other:
• OSDI questionnaire
Ocular Surface Disease Index
• SPEEDII questionnaire
Standardized Patient Evaluation of Eye Dryness II questionnaire

Locations

Country	Name	City	State
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index	Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.	24-72 hours after injection
Secondary	Standardized Patient Evaluation of Eye Dryness II	Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.	24-72 hours after injection