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

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status

Completed

Conditions

Ocular Rinse
Intravitreal Injection
Age-Related Macular Degeneration
Diabetic Macular Edema
Cystoid Macular Edema

Treatments

Other: SPEEDII questionnaire
Other: OSDI questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT05615805
IRB #9810

Details and patient eligibility

About

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.

Full 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.

Enrollment

142 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

142 participants in 3 patient groups

3-mL washout with saline based ocular rinse post injection
Experimental group
Treatment:
Other: SPEEDII questionnaire
Other: OSDI questionnaire
10-mL washout with saline based ocular rinse post injection
Experimental group
Treatment:
Other: SPEEDII questionnaire
Other: OSDI questionnaire
15-mL washout with saline based ocular rinse post injection
Experimental group
Treatment:
Other: SPEEDII questionnaire
Other: OSDI questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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