The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of punctal plugs in reducing ocular surface (eye surface) irritation after intravitreal injections prepared by povidone-iodine 5% solution.

Detailed Description
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Intravitreal injection is a shot of medication into the eye. Many retinal diseases, such as diabetic retinopathy, neovascular age-related macular degeneration, and retinal vein occlusions require regular, periodic injections. Patients often reports eye surface irritation post intravitreal injection. One of the reasons for such discomfort is attributed to povidone-iodine solution used to clean the eye surface to reduce sight-threatening infections. Patients who already experience symptoms of dry eye are at increased risk of discomfort after povidone-iodine prepped intravitreal injections. Povidone-iodine is known to be corrosive to the corneal epithelium and delay eye surface healing. Human tears contain proteins and chemicals that lubricate, heal, and protect the eye surface from infections and irritants. Adequate tear film therefore not only dilutes povidone-iodine, but also promotes corneal healing post povidone-iodine prepping. The primary long-term objective of the present study is to investigate whether punctal plugs will reduce eye discomfort post intravitreal injections as reported by the Ocular Surface Disease Index (OSDI) and other relevant surveys. The secondary outcome is to describe any other risk and protective factors associated with eye surface discomfort after intravitreal injections.

Official Title
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The Effect of Punctal Plugs in Reducing Ocular Surface Irritation After Povidone-Iodine Preparation of Intravitreal Injection

Conditions
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Dry Eye Syndromes, Dry Eye, Ocular Surface Disease

Intervention / Treatment
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* Device: Punctal plug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of age-related macula degeneration Clinical diagnosis of diabetic retinopathy Clinical diagnosis of retinal vein occlusion Exclusion Criteria: Currently wearing punctal plugs History of punctal cautery, Active ocular infection History of ocular infection Eyelid trauma Eyelid surgery Graft versus host disease Thyroid eye disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Puntal plug<br>Subjects will receive temporary punctal plug after intravitreal injection | Device: Punctal plug<br>* Punctal plug will be given to subjects after intravitreal injection in half of the study subjects<br>|
| No Intervention: Non-Punctual plug<br>Subjects will not receive temporary punctal plug after intravitreal injection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular (eye) discomfort | Measure participants' level of discomfort after punctal plugs using the Ocular Surface Disease Index (OSDI), which is a paper survey that participants fill out based on their symptoms and level of ocular discomfort (if any). | From date of randomization until date of death from any cause, whichever came first, assessed up to 100 weeks |