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

Not Applicable

Completed

• Conditions: Ocular Rinse; Age-Related Macular Degeneration; Cystoid Macular Edema; Diabetic Macular Edema; Intravitreal Injection
• Interventions: Other: OSDI questionnaire; Other: SPEEDII questionnaire

• Registration Number: NCT05615805
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-07-30
• Study Completion: 2021-10-01
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15-mL washout with saline based ocular rinse post injection	OSDI questionnaire	-
3-mL washout with saline based ocular rinse post injection	SPEEDII questionnaire	-
10-mL washout with saline based ocular rinse post injection	OSDI questionnaire	-
3-mL washout with saline based ocular rinse post injection	OSDI questionnaire	-
15-mL washout with saline based ocular rinse post injection	SPEEDII questionnaire	-
10-mL washout with saline based ocular rinse post injection	SPEEDII questionnaire	-

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index	24-72 hours after injection	Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.

Secondary Outcome Measures

Name	Time	Method
Standardized Patient Evaluation of Eye Dryness II	24-72 hours after injection	Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.

Trial Locations

Locations (1)

Dean McGee Eye Institute; 🇺🇸 Oklahoma City, Oklahoma, United States