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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: OSDI questionnaire
* Other: SPEEDII questionnaire


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-mL washout with saline based ocular rinse post injection<br> | Other: OSDI questionnaire<br>* Ocular Surface Disease Index<br>Other: SPEEDII questionnaire<br>* Standardized Patient Evaluation of Eye Dryness II questionnaire<br>|
| Experimental: 10-mL washout with saline based ocular rinse post injection<br> | Other: OSDI questionnaire<br>* Ocular Surface Disease Index<br>Other: SPEEDII questionnaire<br>* Standardized Patient Evaluation of Eye Dryness II questionnaire<br>|
| Experimental: 15-mL washout with saline based ocular rinse post injection<br> | Other: OSDI questionnaire<br>* Ocular Surface Disease Index<br>Other: SPEEDII questionnaire<br>* Standardized Patient Evaluation of Eye Dryness II questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index | Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome. | 24-72 hours after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |